Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00401830
• Collaborator: (none)
• Enrollment: 159
• Locations: 25
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Syndrome	Drug: Lacosamide; Other: Placebo	Phase 2

Detailed Description

This was a proof-of-concept study and not powered for statistical comparisons.

The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day or placebo during the Maintenance Phase. Subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly intervals of 100mg. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase. No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

Study Design

• Study Type: Interventional
• Actual Enrollment: 159 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 400 mg/Day Lacosamide Tablets in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Other: Placebo; Matching placebo tablet administered twice daily
Experimental: Lacosamide Lacosamide Tablet 400mg daily	Drug: Lacosamide; Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg; Other Names: Vimpat Harkoseride

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set) [Baseline, Last 2 weeks of the 12-week Treatment Phase]

   The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).

2. Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set) [Baseline, Last 2 weeks of the 12-week Treatment Phase]

   The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).

Secondary Outcome Measures

1. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase [Baseline, Last assessment in the 12-week Treatment Phase]

   The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia

2. Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase [Baseline, Last assessment in the 12-week Treatment Phase]

   Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.

3. Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase [Baseline, Last 2 weeks of the 12-week Treatment Phase]

   Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)

4. Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase [Baseline, Last 2 weeks of the 12-week Treatment Phase]

   General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)

5. Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase [Baseline, Last 2 weeks of the 12 week Treatment Phase]

   An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).

6. Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase [Baseline, Last 2 weeks of the 12 week Treatment Phase]

   An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).

7. Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase [Baseline, Last assessment in the 12-week Treatment Phase]

   The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).

8. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase [Baseline, Last assessment in the 12-week Treatment Phase]

   The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.

9. Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase [12-week Treatment Phase]

   Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.

10. Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase [12-week Treatment Phase]

    Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).

11. Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase [Baseline, Last assessment in the 12-week Treatment Phase]

    All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.

12. Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12 [End of the Maintenance Phase/Week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males or females, 18 to 65 years old

• Fulfills all 3 points of American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia

• At least moderate pain (pain intensity ≥ 5 on Likert pain scale (0-10) during the 7 days prior to Baseline)

• Fibromyalgia Impact Questionnaire (FIQ) total score ≥ 50

• Completed an adequate washout period for excluded medications prior to beginning the Baseline Diary Phase

Exclusion Criteria:

• Symptomatic regional or structural rheumatic disease

• Diagnosed neuropathic pain syndrome

• Receiving treatment with neurostimulating devices

• Significant psychopathology

• History of chronic alcohol or drug abuse within 6 months prior to Screening

• Been hospitalized for psychiatric or behavioral reasons within 6 months prior to Screening

• Clinically significant abnormal vitals, cardiac dysfunction and /or arrhythmias

• Taken neuroleptics, serotonin and norepinephrine reuptake inhibitors (SNRIs) or tricyclic antidepressants (TCAs)

• Other medical conditions that could compromise the subject's ability to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Litchfield Park	Arizona	United States
2		Santa Ana	California	United States	92705
3		Walnut Creek	California	United States	94598
4		Deerfield Beach	Florida	United States	33064
5		Fort Lauderdale	Florida	United States	33334
6		Fort Myers	Florida	United States	33916
7		Tampa	Florida	United States	33614
8		Athens	Georgia	United States
9		Decatur	Georgia	United States	30033
10		Peoria	Illinois	United States	61614
11		Evansville	Indiana	United States	47714
12		Madisonville	Kentucky	United States	42431
13		Columbia	Maryland	United States	21045
14		Frederick	Maryland	United States	21702
15		Brockton	Massachusetts	United States	20301
16		Charlotte	North Carolina	United States	28210
17		Winston-Salem	North Carolina	United States	27103
18		Mogadore	Ohio	United States	44260
19		Toledo	Ohio	United States	43623
20		Goose Creek	South Carolina	United States	29445
21		Memphis	Tennessee	United States	30033
22		San Antonio	Texas	United States	78213
23		San Antonio	Texas	United States
24		Richmond	Virginia	United States	23294
25		Kirkland	Washington	United States	98033

Sponsors and Collaborators

• UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center, [phone] (UCB)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• FDA Safety Alerts and Recalls
• Product Information

Publications

None provided.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00401830
• Other Study ID Numbers: SP0887
• First Posted: Nov 22, 2006
• Last Update Posted: Jul 18, 2018
• Last Verified: Jul 1, 2017

• Keywords provided by UCB Pharma: Fibromyalgia Syndrome; Lacosamide; Vimpat; Harkoseride
• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome; Lacosamide

Study Results

Participant Flow

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Period Title: Overall Study
STARTED	81	78
COMPLETED	50	46
NOT COMPLETED	31	32

Baseline Characteristics

Arm/Group Title	Placebo	Lacosamide	Total
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)	Total of all reporting groups
Overall Participants	81	78	159
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	79 97.5%	76 97.4%	155 97.5%
>=65 years	2 2.5%	2 2.6%	4 2.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.4 (10.5)	48.9 (11.1)	49.7 (10.8)
Sex: Female, Male (Count of Participants)
Female	77 95.1%	71 91%	148 93.1%
Male	4 4.9%	7 9%	11 6.9%
Region of Enrollment (participants) [Number]
United States	81 100%	78 100%	159 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)
Description	The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame	Baseline, Last 2 weeks of the 12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	80	78
Mean (Standard Deviation) [Score on a scale]	-1.30 (1.92)	-1.80 (2.13)

2. Primary Outcome

Title	Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)
Description	The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame	Baseline, Last 2 weeks of the 12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 36 and 41 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	36	41
Mean (Standard Deviation) [Score on a scale]	-2.11 (1.98)	-2.40 (2.08)

3. Secondary Outcome

Title	Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase
Description	The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia
Time Frame	Baseline, Last assessment in the 12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	79	78
Mean (Standard Deviation) [Score on a scale]	-14.7 (16.9)	-17.5 (19.3)

4. Secondary Outcome

Title	Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase
Description	Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.
Time Frame	Baseline, Last assessment in the 12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	79	78
Mean (Standard Deviation) [Score on a scale]	-6.7 (13.6)	-9.7 (13.0)

5. Secondary Outcome

Title	Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase
Description	Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)
Time Frame	Baseline, Last 2 weeks of the 12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	80	78
Mean (Standard Deviation) [Score on a scale]	-1.24 (1.94)	-1.64 (2.16)

6. Secondary Outcome

Title	Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase
Description	General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)
Time Frame	Baseline, Last 2 weeks of the 12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	80	78
Mean (Standard Deviation) [Score on a scale]	-1.27 (1.93)	-1.44 (2.30)

7. Secondary Outcome

Title	Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
Description	An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame	Baseline, Last 2 weeks of the 12 week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	80	78
Mean (Standard Deviation) [Score on a scale]	-1.29 (1.97)	-1.77 (2.18)

8. Secondary Outcome

Title	Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
Description	An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame	Baseline, Last 2 weeks of the 12 week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	80	78
Mean (Standard Deviation) [Score on a scale]	-1.32 (1.94)	-1.84 (2.15)

9. Secondary Outcome

Title	Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase
Description	The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).
Time Frame	Baseline, Last assessment in the 12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have this assessment.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	67	67
Much better	8	17
Moderately better	14	12
Mildly better	18	13
No change	17	13
Mildly worse	5	3
Moderately worse	2	6
Much worse	3	3

10. Secondary Outcome

Title	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase
Description	The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.
Time Frame	Baseline, Last assessment in the 12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have change from Baseline data for depression. One subject in the Lacosamide group had a missing anxiety score.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	67	67
Depression score (Placebo n=67, Lacosamide n=67)	-1.1 (2.8)	-0.8 (2.8)
Anxiety Score (Placebo n=67, Lacosamide n=66)	-1.2 (3.2)	-1.2 (3.2)

11. Secondary Outcome

Title	Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase
Description	Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.
Time Frame	12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	80	78
Number [Percentage of patients]	83.8	83.3

12. Secondary Outcome

Title	Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase
Description	Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).
Time Frame	12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	80	78
Number [Percentage of patients]	17.5	15.4

13. Secondary Outcome

Title	Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase
Description	All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.
Time Frame	Baseline, Last assessment in the 12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 61 and 60 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	61	60
Muscular Pain	-1.9 (2.4)	-2.4 (2.9)
Fatigue	-1.7 (2.4)	-1.9 (2.9)
Insomnia	-1.9 (2.7)	-2.4 (3.2)
Joint pains	-1.9 (2.8)	-1.9 (3.3)
Headaches	-0.7 (3.2)	-1.2 (3.5)
Restless legs	-1.5 (2.9)	-1.2 (3.3)
Paresthesias	-1.6 (2.6)	-1.3 (3.1)
Impaired memory	-1.3 (2.7)	0.0 (3.1)
Leg cramps	-1.5 (2.8)	-1.4 (2.8)
Impaired concentration	-1.2 (3.1)	-0.5 (3.1)
Abdominal pain, alternating diarrhea/constipation	-1.7 (3.4)	-1.2 (3.5)

14. Secondary Outcome

Title	Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12
Time Frame	End of the Maintenance Phase/Week 12

Outcome Measure Data

Analysis Population Description

The number of patients in the Placebo treatment group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 78 patients in the Lacosamide treatment group (Safety Set) data were available at the end of Maintenance Phase/Week 12 for the 45 patients remaining in the study.

Arm/Group Title	Placebo	Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)	Lacosamide Tablet 400mg daily (administered twice daily)
Measure Participants	0	45
Mean (Standard Deviation) [ug/ML]	9.44 (5.24)

Adverse Events

Arm/Group Title	Placebo		Lacosamide
Arm/Group Description	Matching placebo tablet (administered twice daily)		Lacosamide Tablet 400mg daily (administered twice daily)
All Cause Mortality
	Placebo		Lacosamide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Lacosamide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/81 (3.7%)		0/78 (0%)
Infections and infestations
Gastroenteritis	1/81 (1.2%)	1	0/78 (0%)	0
Metabolism and nutrition disorders
Dehydration	1/81 (1.2%)	1	0/78 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/81 (1.2%)	1	0/78 (0%)	0
Nervous system disorders
Cerebrovascular accident	1/81 (1.2%)	1	0/78 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		Lacosamide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/81 (45.7%)		53/78 (67.9%)
Eye disorders
Vision blurred	1/81 (1.2%)	1	4/78 (5.1%)	5
Gastrointestinal disorders
Constipation	3/81 (3.7%)	3	5/78 (6.4%)	5
Diarrhoea	6/81 (7.4%)	7	5/78 (6.4%)	5
Hypoaesthesia oral	0/81 (0%)	0	4/78 (5.1%)	4
Nausea	12/81 (14.8%)	13	13/78 (16.7%)	15
Vomiting	4/81 (4.9%)	4	5/78 (6.4%)	6
General disorders
Fatigue	5/81 (6.2%)	6	4/78 (5.1%)	4
Infections and infestations
Nasopharyngitis	5/81 (6.2%)	5	3/78 (3.8%)	3
Sinusitis	4/81 (4.9%)	4	4/78 (5.1%)	4
Musculoskeletal and connective tissue disorders
Back pain	2/81 (2.5%)	3	4/78 (5.1%)	5
Pain in extremity	0/81 (0%)	0	4/78 (5.1%)	4
Nervous system disorders
Balance disorder	0/81 (0%)	0	4/78 (5.1%)	4
Dizziness	8/81 (9.9%)	9	18/78 (23.1%)	21
Headache	18/81 (22.2%)	20	16/78 (20.5%)	16
Somnolence	3/81 (3.7%)	3	5/78 (6.4%)	5
Psychiatric disorders
Anxiety	4/81 (4.9%)	4	4/78 (5.1%)	4
Skin and subcutaneous tissue disorders
Pruritus	2/81 (2.5%)	2	7/78 (9%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.