Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00313820
• Collaborator: (none)
• Enrollment: 220
• Locations: 33
• Arms: 2
• Duration (Months): 25
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)

Condition or Disease	Intervention/Treatment	Phase
Central Neuropathic Pain	Drug: Pregabalin; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A 13-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150-600 Mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Central Post-Stroke Pain (CPSP)
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pregabalin The change from in pain scores from baseline to endpoint among stroke subjects receiving pregabalin will be compared to change in pain scores from baseline to endpoint among stroke subjects receiving matched placebo.	Drug: Pregabalin; Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
Placebo Comparator: Placebo The change in pain scores from baseline to endpoint will be compared among the two treatment groups- ie subjects receiving 12 weeks of pregabalin treatment vs subjects receiving 12 weeks of placebo treatment.	Drug: Placebo; Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.

Outcome Measures

Primary Outcome Measures

1. Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS) [Up to Week 12]

   Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.

Secondary Outcome Measures

1. Pain Score as Measured by DPRS [Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12]

   Weekly mean pain score measured by DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.

2. Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint [Baseline, Week 12]

   30% Responder Yes = number of subjects with 30% reduction in mean pain score from baseline to observation; 30% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 30. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 30% Responder No indicates number of subjects that did not reach 30% reduction in mean pain score.

3. Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint [Baseline, Week 12]

   50% Responder Yes = number of subjects with 50% reduction in mean pain score from baseline to observation; 50% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 50. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 50% Responder No indicates number of subjects that did not reach 50% reduction in mean pain score.

4. Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS]) [Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12]

   DSIS: subject rated 11-point numeric scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. Endpoint calculated as mean of last 7 available scores.

5. Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only [Week 12]

   SF-MPQ Part B VAS consists of a line 0 to 100 millimeters (mm) in length; range is (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.

6. Neuropathic Pain Symptom Inventory (NPSI) [Week 12]

   NPSI: subject rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score (0 to 100). Higher score indicates a greater intensity of pain.

7. Medical Outcome Study (MOS) Sleep Scale [Week 12]

   MOS: subject rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.

8. Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep [Week 12]

   MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of subjects with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night.

9. Hospital Anxiety and Depression Scale (HADS) - ITT Population [Week 12]

   HADS is subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.

10. Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [Week 12]

    EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

11. EQ-5D - VAS [Week 12]

    EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

12. Patient Global Impression of Change (PGIC) [Week 12]

    PGIC: subject rated instrument to measure subject's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).

13. Clinical Global Impression of Change (CGIC) [Week 12]

    CGIC: clinician rated instrument that measures change in a subject's ovall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).

14. Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold [Baseline, Week 12]

    QANeP: assessment of sensory threshold: subject responds "yes" when monofilament stimulus is felt on area of maximum pain: 1 (lowest/softest 0.07 gram [g]) to 6 (highest 300 g) or 7 (not perceived); rated by lowest/softest filament felt when in contact with the skin. Summarized as change from baseline (mean at observation minus mean at baseline).

15. QANeP - Pain Rating Scales [Baseline, Week 12]

    Subject rated pain scale: static mechanical allodynia (SMA) gentle constant mechanical pressure; dynamic mechanical allodynia (DMA) gentle stroking with foam brush; punctate hyperalgesia (PH) pinprick; cold allodynia (CA) touch with cool metal rod 13-17° celsius (C); cold hyperalgesia (CH) touch with cold metal rod 4° C; temporal summation to tactile stimuli (TSTS) repeated touching/tapping. 11-point numeric scale; range 0 (no pain) to 10 (worst possible pain). Reference area=mirror image of pain site (test area). Summarized as change from baseline (mean at observation minus mean at baseline).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Positive history of clinical stroke at least 4 months prior to randomization CPSP--3 months prior to screening

Exclusion Criteria:

• History of dementia or any other severe cognitive impairment

• Diabetic Peripheral Neuropathy (DPN)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Darlinghurst	New South Wales	Australia	2010
2	Pfizer Investigational Site	East Gosford	New South Wales	Australia	2250
3	Pfizer Investigational Site	St Leonards	New South Wales	Australia	2065
4	Pfizer Investigational Site	Warrawong	New South Wales	Australia	2502
5	Pfizer Investigational Site	Herston	Queensland	Australia
6	Pfizer Investigational Site	Footscray	Victoria	Australia	3011
7	Pfizer Investigational Site	Perth	Western Australia	Australia	6000
8	Pfizer Investigational Site	Beijing		China	100083
9	Pfizer Investigational Site	Beijing		China	100730
10	Pfizer Investigational Site	Guang Zhou		China	510180
11	Pfizer Investigational Site	Shang Hai		China	200003
12	Pfizer Investigational Site	Shang Hai		China	200040
13	Pfizer Investigational Site	New Territories		Hong Kong
14	Pfizer Investigational Site	Bangalore		India	560 034
15	Pfizer Investigational Site	Bangalore		India	560 054
16	Pfizer Investigational Site	Chennai		India	600 010
17	Pfizer Investigational Site	Lucknow		India	226 014
18	Pfizer Investigational Site	New Delhi		India	110 002
19	Pfizer Investigational Site	Jakarta		Indonesia	10430
20	Pfizer Investigational Site	Surabaya		Indonesia	60286
21	Pfizer Investigational Site	Seoul		Korea, Republic of	138-736
22	Pfizer Investigational Site	Kuala Lumpur		Malaysia	59100
23	Pfizer Investigational Site	Penang		Malaysia	11600
24	Pfizer Investigational Site	Selangor		Malaysia	68100
25	Pfizer Investigational Site	Karachi	Sindh	Pakistan
26	Pfizer Investigational Site	Karachi		Pakistan
27	Pfizer Investigational Site	Manila		Philippines	1000
28	Pfizer Investigational Site	Manila		Philippines	1003
29	Pfizer Investigational Site	Gueishan Shiang	Taoyuan Hsien	Taiwan
30	Pfizer Investigational Site	Taichung		Taiwan	407
31	Pfizer Investigational Site	Taipei		Taiwan	112
32	Pfizer Investigational Site	Ratchatewee	Bangkok	Thailand	10400
33	Pfizer Investigational Site	Bangkok		Thailand	10400

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00313820
• Other Study ID Numbers: A0081063
• First Posted: Apr 12, 2006
• Last Update Posted: Feb 9, 2021
• Last Verified: Oct 1, 2009

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Post-stroke pain, pregabalin
• Additional relevant MeSH terms: Neuralgia; Pregabalin

Study Results

Participant Flow

Pre-assignment Detail	Two-week screening and washout phase prior to randomization.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Period Title: Assigned to Treatment
STARTED	111	109
COMPLETED	110	109
NOT COMPLETED	1	0
Period Title: Assigned to Treatment
STARTED	110	109
COMPLETED	93	90
NOT COMPLETED	17	19

Baseline Characteristics

Arm/Group Title	Pregabalin	Placebo	Total
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	Total of all reporting groups
Overall Participants	110	109	219
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.4 (9.8)	57.1 (10.2)	58.2 (10.0)
Sex: Female, Male (Count of Participants)
Female	43 39.1%	39 35.8%	82 37.4%
Male	67 60.9%	70 64.2%	137 62.6%

Outcome Measures

1. Primary Outcome

Title	Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)
Description	Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT): received at least 1 dose study medication and completed at least 1 post-baseline assessment. Endpoint = Week 12 or ET

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	108	108
Least Squares Mean (Standard Error) [scores on scale]	4.8 (0.21)	5.0 (0.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Modelled Results: Endpoint Mean Pain Score Pregabalin vs Placebo
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.578
	Comments
	Method	ANCOVA
	Comments	ANCOVA with treatment and country as factors and baseline pain score as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	() 95%; -0.7 to 0.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Modelled Results: Treatment by country interaction
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.294
	Comments	Interaction p-value based on adding interaction term to the main model.
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Pain Score as Measured by DPRS
Description	Weekly mean pain score measured by DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.
Time Frame	Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12

Outcome Measure Data

Analysis Population Description

ITT; (n) = number of participants with analyzable data at observation for pregabalin and placebo, respectively; weeks as specified in timeframe through Week 12 [ET]

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	110	109
Week 1 (n=108, 108)	5.6 (0.18)	6.0 (0.18)
Week 2 (n=104, 106)	5.3 (0.18)	5.8 (0.18)
Week 3 (n=102, 105)	5.1 (0.18)	5.6 (0.18)
Week 6 (n=97, 102)	4.9 (0.18)	5.4 (0.18)
Week 9 (n=98, 97)	4.8 (0.18)	5.2 (0.18)
Week 12 [ET] (n=92, 92)	4.7 (0.18)	4.9 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 1 Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.161
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3
	Confidence Interval	() 95%; -0.8 to 0.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 2 Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.062
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.5
	Confidence Interval	() 95%; -1.0 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 3 Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.024
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.6
	Confidence Interval	() 95%; -1.1 to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 6 Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.026
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.6
	Confidence Interval	() 95%; -1.1 to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 9 Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.105
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	() 95%; -0.9 to 0.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 12 Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.592
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	() 95%; -0.6 to 0.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

3. Secondary Outcome

Title	Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint
Description	30% Responder Yes = number of subjects with 30% reduction in mean pain score from baseline to observation; 30% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 30. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 30% Responder No indicates number of subjects that did not reach 30% reduction in mean pain score.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

ITT; endpoint = Week 12 or ET

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	108	108
30% Responders Yes	48 43.6%	35 32.1%
30% Responders No	60 54.5%	73 67%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	30% Responders
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.087
	Comments	Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.
	Method	Cochran-Mantel-Haenszel
	Comments

4. Secondary Outcome

Title	Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint
Description	50% Responder Yes = number of subjects with 50% reduction in mean pain score from baseline to observation; 50% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 50. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 50% Responder No indicates number of subjects that did not reach 50% reduction in mean pain score.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

ITT; endpoint = Week 12 or ET

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	108	108
50 % Responders Yes	26 23.6%	22 20.2%
50 % Responders No	82 74.5%	86 78.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	50% Responders
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.622
	Comments	Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.
	Method	Cochran-Mantel-Haenszel
	Comments

5. Secondary Outcome

Title	Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])
Description	DSIS: subject rated 11-point numeric scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. Endpoint calculated as mean of last 7 available scores.
Time Frame	Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12

Outcome Measure Data

Analysis Population Description

ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; endpoint = Week 12 or ET.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	110	109
Week 1 (n=108, 108)	3.6 (0.17)	4.2 (0.17)
Week 2 (n=104, 106)	3.5 (0.17)	4.0 (0.17)
Week 3 (n=102, 105)	3.2 (0.17)	3.9 (0.17)
Week 6 (n=98, 102)	3.0 (0.17)	3.7 (0.17)
Week 9 (n=98, 97)	3.0 (0.17)	3.4 (0.17)
Week 12 (n=92, 92)	3.1 (0.18)	3.2 (0.18)
Endpoint [Week 12 or ET] (n=108, 108)	3.0 (0.19)	3.1 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 1; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.5
	Confidence Interval	() 95%; -1.0 to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 2; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.038
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.5
	Confidence Interval	() 95%; -1.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 3; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.7
	Confidence Interval	() 95%; -1.2 to -0.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 6; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.7
	Confidence Interval	() 95%; -1.1 to -0.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 9; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.078
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	() 95%; -0.9 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 12; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.663
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	() 95%; -0.6 to 0.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Endpoint [Week 12 or ET]; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.627
	Comments	Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	() 95%; -0.6 to 0.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

6. Secondary Outcome

Title	Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only
Description	SF-MPQ Part B VAS consists of a line 0 to 100 millimeters (mm) in length; range is (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	100	97
Least Squares Mean (Standard Error) [millimeters]	48.5 (2.19)	49.5 (2.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.741
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline value as a covariate
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.0
	Confidence Interval	() 95%; -7.0 to 5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.05
	Estimation Comments

7. Secondary Outcome

Title	Neuropathic Pain Symptom Inventory (NPSI)
Description	NPSI: subject rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score (0 to 100). Higher score indicates a greater intensity of pain.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT; (N) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12/Last observation carried forward (LOCF).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	110	109
Burning Pain (n=108, 108)	2.6 (0.22)	2.9 (0.23)
Pressing Pain (n=108, 107)	2.7 (0.18)	2.6 (0.19)
Paroxysmal Pain (n=108, 108)	1.9 (0.18)	2.1 (0.18)
Evoked Pain (n=108, 108)	2.8 (0.19)	3.2 (0.19)
P/D (n=108, 108)	2.7 (0.20)	3.1 (0.20)
Total Score (n=108, 107)	25.7 (1.36)	28.5 (1.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Burning Pain Week 12 [LOCF]; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.216
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	() 95%; -1.0 to 0.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.31
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Pressing Pain Week 12 [LOCF]; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.760
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.1
	Confidence Interval	() 95%; -0.4 to 0.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Paroxysmal Pain Week 12 [LOCF]; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.360
	Comments	Estimated from ANCOVA (general linear model) general linear model with treatment and country as factors and baseline score as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	() 95%; -0.7 to 0.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Evoked Pain Week 12 [LOCF]; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.239
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3
	Confidence Interval	() 95%; -0.8 to 0.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	P/D Week 12 [LOCF]; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.118
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	() 95%; -1.0 to 0.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Total Score Week 12 [LOCF]; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.138
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.8
	Confidence Interval	() 95%; -6.5 to 0.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.87
	Estimation Comments

8. Secondary Outcome

Title	Medical Outcome Study (MOS) Sleep Scale
Description	MOS: subject rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	110	109
Sleep disturbance (n=100, 97)	27.1 (2.00)	31.9 (2.05)
Snoring score (n=98, 97)	40.6 (2.68)	32.9 (2.75)
Awaken SOB or headache (n=99, 97)	11.3 (1.95)	15.0 (1.99)
Sleep quantity (100, 97)	7.0 (0.12)	6.6 (0.12)
Sleep adequacy (n=99, 97)	67.5 (2.48)	58.9 (2.51)
Somnolence (n=99, 97)	39.9 (1.81)	37.8 (1.84)
Overall sleep problems index (n=100, 97)	28.2 (1.53)	32.4 (1.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Sleep disturbance; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.086
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.8
	Confidence Interval	() 95%; -10.3 to 0.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.79
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Snoring score; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.039
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.7
	Confidence Interval	() 95%; 0.4 to 15.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.72
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Awaken SOB or headache; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.169
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.7
	Confidence Interval	() 95%; -9.1 to 1.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.71
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Sleep quantity; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.4
	Confidence Interval	() 95%; 0.0 to 0.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Sleep adequacy; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.013
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.6
	Confidence Interval	() 95%; 1.8 to 15.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.44
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Somnolence; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.399
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.1
	Confidence Interval	() 95%; -2.8 to 7.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.51
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Overall sleep problems index; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.049
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.2
	Confidence Interval	() 95%; -8.4 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.13
	Estimation Comments

9. Secondary Outcome

Title	Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep
Description	MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of subjects with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	100	97
Optimal sleep = Yes	51 46.4%	42 38.5%
Optimal sleep = No	49 44.5%	55 50.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.201
	Comments	Estimated from a logistic regression model with treatment and the baseline assessment as factors.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.5
	Confidence Interval	() 95%; 0.8 to 2.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.50
	Estimation Comments	Standard error of the mean = standard error of the odds ratio.

10. Secondary Outcome

Title	Hospital Anxiety and Depression Scale (HADS) - ITT Population
Description	HADS is subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT; Week 12 [LOCF]

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	108	108
Week 12 [LOCF] Anxiety score	5.5 (0.29)	6.5 (0.30)
Week 12 [LOCF] Depression score	6.7 (0.30)	6.5 (0.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 12 [LOCF] Anxiety score; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.015
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.0
	Confidence Interval	() 95%; -1.8 to -0.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.40
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 12 [LOCF] Depression score; Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.600
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.2
	Confidence Interval	() 95%; -0.6 to 1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.41
	Estimation Comments

11. Secondary Outcome

Title	Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
Description	EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	98	97
Least Squares Mean (Standard Error) [scores on scale]	0.5 (0.03)	0.5 (0.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.566
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.0
	Confidence Interval	() 95%; -0.1 to 0.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.04
	Estimation Comments

12. Secondary Outcome

Title	EQ-5D - VAS
Description	EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	99	97
Least Squares Mean (Standard Error) [scores on scale]	65.7 (1.78)	62.7 (1.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.220
	Comments	Estimated from ANCOVA (general linear model) with treatment and coutntry as factors and baseline score as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.0
	Confidence Interval	() 95%; -1.8 to 7.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.47
	Estimation Comments

13. Secondary Outcome

Title	Patient Global Impression of Change (PGIC)
Description	PGIC: subject rated instrument to measure subject's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	99	97
Least Squares Mean (Standard Error) [scores on scale]	2.9 (0.10)	3.1 (0.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.144
	Comments	Estimated from ANCOVA (general linear model) with treament and country as factors.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	() 95%; -0.5 to 0.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.14
	Estimation Comments

14. Secondary Outcome

Title	Clinical Global Impression of Change (CGIC)
Description	CGIC: clinician rated instrument that measures change in a subject's ovall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	101	97
Least Squares Mean (Standard Error) [scores on scale]	2.8 (0.10)	3.1 (0.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Modelled Results
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.049
	Comments	Estimated from ANCOVA (general linear model) with treatment and country as factors.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3
	Confidence Interval	() 95%; -0.6 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.14
	Estimation Comments

15. Secondary Outcome

Title	Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold
Description	QANeP: assessment of sensory threshold: subject responds "yes" when monofilament stimulus is felt on area of maximum pain: 1 (lowest/softest 0.07 gram [g]) to 6 (highest 300 g) or 7 (not perceived); rated by lowest/softest filament felt when in contact with the skin. Summarized as change from baseline (mean at observation minus mean at baseline).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

ITT; Week 12 [LOCF].

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	106	107
Mean (Standard Deviation) [scores on scale]	0.0 (0.89)	-0.1 (0.83)

16. Secondary Outcome

Title	QANeP - Pain Rating Scales
Description	Subject rated pain scale: static mechanical allodynia (SMA) gentle constant mechanical pressure; dynamic mechanical allodynia (DMA) gentle stroking with foam brush; punctate hyperalgesia (PH) pinprick; cold allodynia (CA) touch with cool metal rod 13-17° celsius (C); cold hyperalgesia (CH) touch with cold metal rod 4° C; temporal summation to tactile stimuli (TSTS) repeated touching/tapping. 11-point numeric scale; range 0 (no pain) to 10 (worst possible pain). Reference area=mirror image of pain site (test area). Summarized as change from baseline (mean at observation minus mean at baseline).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12 [LOCF].

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Measure Participants	110	109
SMA (n=108, 107)	-0.7 (2.14)	-0.5 (1.93)
DMA (n=108, 107)	-0.8 (1.96)	-0.6 (1.83)
PH reference area (n=108, 107)	-0.2 (2.60)	-0.2 (2.41)
PH test area (n=108, 107)	-0.7 (2.27)	-0.0 (2.37)
TSTS (n=108, 106)	-1.0 (2.47)	-0.5 (2.25)
CA (n=108, 106)	-1.1 (2.36)	-0.3 (1.95)
CH reference area (n=107, 107)	0.0 (2.56)	-0.2 (1.74)
CH test area (n=107, 106)	-0.9 (2.47)	-0.9 (2.14)

Adverse Events

Arm/Group Title	Pregabalin		Placebo
Arm/Group Description	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.		75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
All Cause Mortality
	Pregabalin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pregabalin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/110 (5.5%)		2/109 (1.8%)
Cardiac disorders
Acute myocardial infarction	1/110 (0.9%)		0/109 (0%)
General disorders
Local swelling	1/110 (0.9%)		0/109 (0%)
Edema peripheral	1/110 (0.9%)		0/109 (0%)
Infections and infestations
Kidney infection	1/110 (0.9%)		0/109 (0%)
Pneumonia	1/110 (0.9%)		0/109 (0%)
Injury, poisoning and procedural complications
Fall	0/110 (0%)		1/109 (0.9%)
Rib fracture	0/110 (0%)		1/109 (0.9%)
Metabolism and nutrition disorders
Hypoglycemia	1/110 (0.9%)		0/109 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness	1/110 (0.9%)		0/109 (0%)
Neck pain	1/110 (0.9%)		0/109 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine	1/110 (0.9%)		0/109 (0%)
Prostate cancer	1/110 (0.9%)		0/109 (0%)
Nervous system disorders
Convulsion	0/110 (0%)		1/109 (0.9%)
Dizziness	1/110 (0.9%)		0/109 (0%)
Renal and urinary disorders
Hydronephrosis	1/110 (0.9%)		0/109 (0%)
Other (Not Including Serious) Adverse Events
	Pregabalin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/110 (53.6%)		25/109 (22.9%)
Gastrointestinal disorders
Diarrhoea	6/110 (5.5%)		2/109 (1.8%)
General disorders
Oedema	6/110 (5.5%)		0/109 (0%)
Oedema peripheral	10/110 (9.1%)		3/109 (2.8%)
Infections and infestations
Upper respiratory tract infection	3/110 (2.7%)		6/109 (5.5%)
Investigations
Weight increased	6/110 (5.5%)		2/109 (1.8%)
Nervous system disorders
Dizziness	31/110 (28.2%)		8/109 (7.3%)
Headache	7/110 (6.4%)		8/109 (7.3%)
Somnolence	24/110 (21.8%)		5/109 (4.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.