SP888: The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00464737
• Collaborator: (none)
• Enrollment: 230
• Locations: 35
• Arms: 3
• Duration (Months): 20.1
• Patients Per Site: 6.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain, sleep, general activity, mood, and quality of life, and the use of rescue medication to treat pain will be assessed.

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

Detailed Description

The overall post-Baseline duration of treatment was 13 weeks. The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week De-escalation Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo during the Maintenance Phase. During the 4-week Titration Phase, subjects assigned to rotigotine were titrated at weekly intervals of 2 mg/24 hrs until they reached 4 mg/24 hrs or 8 mg/24 hrs. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase and were maintained at their randomized dose (rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo). 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: 230 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 2 Different Doses of Rotigotine in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo	Other: Placebo; Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.
Experimental: Rotigotine 4 mg 4 mg/24 hrs	Drug: Rotigotine; Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch); Other Names: Neupro
Experimental: Rotigotine 8 mg 8 mg/24 hrs	Drug: Rotigotine; Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches); Other Names: Neupro

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. 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]).

6. Change From Baseline in Morning and Evening Pain Scores 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. Number of Subjects Using Rescue Medication and Alcohol 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. Use of alcohol to treat pain in the past 24 hours was recorded with a Yes/No response.

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

9. 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.

10. 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.

11. Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase [Baseline, Last assessment in the 12-week Treatment Phase]

    The Beck Depression Inventory-II is a 21-item questionnaire. Each item is scored on a scale of 0 to 3 with a total score ranging from 0 to 63. A higher total score is associated with more severe depressive symptoms.

12. Number of Subjects With Presence of Impulse Control Disorders [12-week Treatment Phase]

    Impulse control disorders (ICDs) are a set of psychiatric disorders in which a person is unable to control strong and often harmful impulses. They are assessed in this study using the Jay Modified Minnesota Impulsive Disorders Interview (Jay Modified MIDI), which focuses on the five most common ICDs that may be associated with dopamine agonist use: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding (performing repetitive and/or mechanical tasks).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subject is male or female, 18 to 65 years of age (inclusive)

• Subject fulfills all 3 points of the American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia (pain, stiffness, and/or sleep disorder)

• Subject must complete an adequate washout period for excluded medications, as necessary, prior to beginning the Baseline Diary Phase

• Subject has at least moderate pain that is defined as an average pain intensity of ≥5 on an 11-point Likert pain scale (0-10) during the 7 days prior to Baseline

• Subject must have at least 5 morning and 5 evening Likert pain scale scores for the 7 days immediately prior to Visit 2 and the average daily pain score over these 7 days must be ≥5 (average daily pain score is determined as follows: calculate the mean of the morning and evening scores separately using all pain scores for the 7 days immediately prior to Visit 2; add the mean morning and evening scores and divide by 2)

• Subject has a score of ≥50 on Fibromyalgia Impact Questionnaire (FIQ), with a score of 100 representing severe disease at Baseline

Exclusion Criteria:

• Subject has symptomatic regional or structural rheumatic disease (eg, knee or hip osteoarthritis, bursitis, tendonitis), rheumatic autoimmune disease or inflammatory rheumatic disease, such as systemic lupus erythematosus (SLE), mild primary osteoarthritis of the hand(s) is allowed

• Subject has diagnosed neuropathic pain syndrome

• Subject has received therapy with a dopamine agonist (eg, pramipexole, ropinirole) for 3 months or longer that was not considered effective in managing fibromyalgia symptoms

• Subject is receiving disability or is involved in litigation related to fibromyalgia syndrome

• Subject has significant psychopathology as determined by the investigator based on results of the Structural Clinical Interview for DSM-IV Diagnosis (SCID-I). The SCID-I must be administered by a physician or clinical psychologist trained to administer the instrument

• Subject has evidence of an impulse control disorder according to the Jay Modified Minnesota Impulsive Disorders Interview (MIDI)

• Subject has any medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's ability to participate in this trial

• Subject has orthostatic hypotension with a decrease of blood pressure (BP) from supine to standing position of ≥20 mmHg in systolic blood pressure (SBP) or of ≥10 mmHg in diastolic blood pressure (DBP) taken from the 5-minute supine value and the 1- and/or 3-minute standing measurements, or supine SBP <105 mmHg at Baseline

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Mobile	Alabama	United States
2		Mesa	Arizona	United States
3		Peoria	Arizona	United States	85381
4		Santa Ana	California	United States	92705
5		Cromwell	Connecticut	United States	06416
6		Deland	Florida	United States	32720
7		Fort Myers	Florida	United States
8		Gainesville	Florida	United States	32611
9		Ocala	Florida	United States
10		Orlando	Florida	United States	32806
11		Palm Beach	Florida	United States
12		Sunrise	Florida	United States
13		Tampa	Florida	United States	33606
14		Columbia	Maryland	United States
15		Springfield	Massachusetts	United States	01103
16		St. Louis	Missouri	United States	63141
17		Stratford	New Jersey	United States
18		Albuquerque	New Mexico	United States
19		New York	New York	United States	10022
20		Rochester	New York	United States
21		Williamsville	New York	United States
22		Charlotte	North Carolina	United States
23		Raleigh	North Carolina	United States	27612
24		Cleveland	Ohio	United States	44122
25		Dayton	Ohio	United States	45408
26		Oklahoma City	Oklahoma	United States	73112
27		Portland	Oregon	United States
28		Souderton	Pennsylvania	United States
29		Crossville	Tennessee	United States
30		Dallas	Texas	United States
31		San Antonio	Texas	United States
32		Bountiful	Utah	United States
33		Woodstock	Vermont	United States	05091
34		Richmond	Virginia	United States
35		Seattle	Washington	United States	98104

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:

• For Safety Alerts amd Recalls refer to

Publications

None provided.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00464737
• Other Study ID Numbers: SP888
• First Posted: Apr 24, 2007
• Last Update Posted: Jun 22, 2015
• Last Verified: Sep 1, 2010

• Keywords provided by UCB Pharma: Fibromyalgia Syndrome; Rotigotine; Neupro
• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome; Rotigotine

Study Results

Participant Flow

Recruitment Details	The Full Analysis Set (FAS) contains all randomized subjects who received at least 1 dose of trial medication, and had at least 1 post-Baseline Likert pain score. The Per Protocol Set contains all subjects in the FAS who completed at least 2 weeks of the Maintenance Phase and had no major protocol deviations.
Pre-assignment Detail	Participant flow is based on the 230 randomized subjects however 1 subject randomized to Rotigotine 4 mg/24 hrs did not receive study medication and was excluded from the Safety Set. Thus 229 subjects are included in summaries of baseline characteristics and adverse events. The excluded subject was a 47-year old female enrolled in the United States

Arm/Group Title	Placebo	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Period Title: Overall Study
STARTED	82	74	74
COMPLETED	50	42	19
NOT COMPLETED	32	32	55

Baseline Characteristics

Arm/Group Title	Placebo	Rotigotine 4 mg	Rotigotine 8 mg	Total
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs	Total of all reporting groups
Overall Participants	82	73	74	229
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	81 98.8%	73 100%	73 98.6%	227 99.1%
>=65 years	1 1.2%	0 0%	1 1.4%	2 0.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.4 (10.7)	47.5 (10.3)	47.0 (11.6)	47.0 (10.8)
Sex: Female, Male (Count of Participants)
Female	76 92.7%	65 89%	68 91.9%	209 91.3%
Male	6 7.3%	8 11%	6 8.1%	20 8.7%
Region of Enrollment (participants) [Number]
United States	82 100%	73 100%	74 100%	229 100%

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 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 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	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	81	70	72
Mean (Standard Deviation) [Score on a scale]	-1.12 (1.83)	-1.27 (1.86)	-0.83 (1.70)

2. 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 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 80, 64 and 63 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	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	80	64	63
Mean (Standard Deviation) [Score on a scale]	-14.9 (15.6)	-13.4 (13.7)	-12.8 (18.1)

3. 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

Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.

Arm/Group Title	Placebo	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	0	0	0

4. 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 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 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	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	81	70	72
Mean (Standard Deviation) [Score on a scale]	-0.95 (2.01)	-0.82 (2.03)	-0.48 (2.09)

5. 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 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 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	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	81	70	72
Mean (Standard Deviation) [Score on a scale]	-1.11 (2.05)	-1.19 (1.82)	-0.88 (2.10)

6. 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 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 76, 58, and 51 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	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	76	58	51
Much better	8	10	9
Moderately better	14	14	7
Mildly better	25	12	11
No change	16	17	12
Mildly worse	5	3	5
Moderately worse	7	1	5
Much worse	1	1	2

7. Secondary Outcome

Title	Change From Baseline in Morning and Evening Pain Scores 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 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 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	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	81	70	72
Morning Pain Score	-1.07 (1.91)	-1.30 (1.91)	-0.78 (1.78)
Evening Pain Score	-1.17 (1.82)	-1.24 (1.90)	-0.88 (1.89)

8. Secondary Outcome

Title	Number of Subjects Using Rescue Medication and Alcohol 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. Use of alcohol to treat pain in the past 24 hours was recorded with a Yes/No response.
Time Frame	12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.

Arm/Group Title	Placebo	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	0	0	0

9. Secondary Outcome

Title	Rotigotine 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 group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 73 (Rotigotine 4 mg) and 74 (Rotigotine 8 mg) patients respectively in the Safety Set, a total of 41 and 20 patients respectively at the end of Maintenance Phase/Week 12 have this assessment.

Arm/Group Title	Placebo	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	0	41	20
Mean (Standard Deviation) [ug/ML]	0.2388 (0.2337)	0.2981 (0.2973)

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

Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.

Arm/Group Title	Placebo	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	0	0	0

11. 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

Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.

Arm/Group Title	Placebo	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	0	0	0

12. Secondary Outcome

Title	Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase
Description	The Beck Depression Inventory-II is a 21-item questionnaire. Each item is scored on a scale of 0 to 3 with a total score ranging from 0 to 63. A higher total score is associated with more severe depressive symptoms.
Time Frame	Baseline, Last assessment in the 12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.

Arm/Group Title	Placebo	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	0	0	0

13. Secondary Outcome

Title	Number of Subjects With Presence of Impulse Control Disorders
Description	Impulse control disorders (ICDs) are a set of psychiatric disorders in which a person is unable to control strong and often harmful impulses. They are assessed in this study using the Jay Modified Minnesota Impulsive Disorders Interview (Jay Modified MIDI), which focuses on the five most common ICDs that may be associated with dopamine agonist use: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding (performing repetitive and/or mechanical tasks).
Time Frame	12-week Treatment Phase

Outcome Measure Data

Analysis Population Description

Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.

Arm/Group Title	Placebo	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	0	0	0

14. 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 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 50, 33 and 22 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	Rotigotine 4 mg	Rotigotine 8 mg
Arm/Group Description	Placebo	Rotigotine 4 mg/24 hrs	Rotigotine 8 mg/24 hrs
Measure Participants	50	33	22
Mean (Standard Deviation) [score on a scale]	-1.28 (1.79)	-2.09 (2.07)	-1.57 (2.27)

Adverse Events

Adverse Event Reporting Description	The Safety Set (SS) is comprised of all subjects who received at least 1 dose of trial medication.
Arm/Group Title	Placebo		Rotigotine 4 mg		Rotigotine 8 mg
Arm/Group Description	Placebo		Rotigotine 4 mg/24 hrs		Rotigotine 8 mg/24 hrs
All Cause Mortality
	Placebo		Rotigotine 4 mg		Rotigotine 8 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Rotigotine 4 mg		Rotigotine 8 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/82 (4.9%)		1/73 (1.4%)		1/74 (1.4%)
General disorders
Chest pain	0/82 (0%)	0	1/73 (1.4%)	1	0/74 (0%)	0
Hepatobiliary disorders
Cholelithiasis	0/82 (0%)	0	0/73 (0%)	0	1/74 (1.4%)	1
Infections and infestations
Pneumonia	1/82 (1.2%)	1	0/73 (0%)	0	0/74 (0%)	0
Injury, poisoning and procedural complications
Ankle fracture	1/82 (1.2%)	1	0/73 (0%)	0	0/74 (0%)	0
Lung injury	1/82 (1.2%)	1	0/73 (0%)	0	0/74 (0%)	0
Rib fracture	1/82 (1.2%)	1	0/73 (0%)	0	0/74 (0%)	0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	1/82 (1.2%)	1	0/73 (0%)	0	0/74 (0%)	0
Nervous system disorders
Intracranial hypotension	1/82 (1.2%)	1	0/73 (0%)	0	0/74 (0%)	0
Nerve compression	1/82 (1.2%)	1	0/73 (0%)	0	0/74 (0%)	0
Trigeminal neuralgia	1/82 (1.2%)	1	0/73 (0%)	0	0/74 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pleural effusion	1/82 (1.2%)	2	0/73 (0%)	0	0/74 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		Rotigotine 4 mg		Rotigotine 8 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	53/82 (64.6%)		55/73 (75.3%)		65/74 (87.8%)
Gastrointestinal disorders
Abdominal pain upper	2/82 (2.4%)	3	0/73 (0%)	0	4/74 (5.4%)	4
Constipation	5/82 (6.1%)	6	5/73 (6.8%)	5	5/74 (6.8%)	6
Diarrhoea	6/82 (7.3%)	7	5/73 (6.8%)	5	8/74 (10.8%)	8
Dry mouth	3/82 (3.7%)	3	5/73 (6.8%)	6	7/74 (9.5%)	7
Nausea	18/82 (22%)	25	34/73 (46.6%)	46	48/74 (64.9%)	63
Vomiting	1/82 (1.2%)	1	13/73 (17.8%)	15	18/74 (24.3%)	22
General disorders
Application site irritation	1/82 (1.2%)	1	6/73 (8.2%)	6	5/74 (6.8%)	6
Application site pruritus	4/82 (4.9%)	5	3/73 (4.1%)	3	11/74 (14.9%)	11
Fatigue	2/82 (2.4%)	4	5/73 (6.8%)	6	1/74 (1.4%)	1
Infections and infestations
Sinusitis	6/82 (7.3%)	7	2/73 (2.7%)	2	0/74 (0%)	0
Upper respiratory tract infection	1/82 (1.2%)	1	7/73 (9.6%)	7	2/74 (2.7%)	3
Musculoskeletal and connective tissue disorders
Muscle spasms	5/82 (6.1%)	5	2/73 (2.7%)	2	4/74 (5.4%)	4
Nervous system disorders
Dizziness	6/82 (7.3%)	6	10/73 (13.7%)	10	8/74 (10.8%)	10
Headache	12/82 (14.6%)	17	13/73 (17.8%)	18	12/74 (16.2%)	15
Somnolence	6/82 (7.3%)	6	8/73 (11%)	9	7/74 (9.5%)	9
Psychiatric disorders
Anxiety	2/82 (2.4%)	2	1/73 (1.4%)	1	4/74 (5.4%)	4
Insomnia	4/82 (4.9%)	4	6/73 (8.2%)	10	7/74 (9.5%)	9
Respiratory, thoracic and mediastinal disorders
Hiccups	0/82 (0%)	0	3/73 (4.1%)	3	4/74 (5.4%)	7
Skin and subcutaneous tissue disorders
Pruritus	1/82 (1.2%)	1	4/73 (5.5%)	4	4/74 (5.4%)	4
Rash	5/82 (6.1%)	6	3/73 (4.1%)	3	4/74 (5.4%)	4

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 is confidential and 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.