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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Rotigotine 4 mg | Experimental | 4 mg/24 hrs |
|
| Rotigotine 8 mg | Experimental | 8 mg/24 hrs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine | Drug | Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced). | Baseline, Last 2 weeks of the 12-week Treatment Phase |
| 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) | The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced). | Baseline, Last 2 weeks of the 12-week Treatment Phase |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the 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 | Baseline, Last assessment in the 12-week Treatment Phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | United States | ||||
Not provided
| Label | URL |
|---|---|
| For Safety Alerts amd Recalls refer to | View source |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo |
| FG001 | Rotigotine 4 mg | Rotigotine 4 mg/24 hrs |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rotigotine | Drug | Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches) |
|
|
| Placebo | Other | Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches. |
|
| Change From Baseline in Total Myalgic Score to the 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. |
| Baseline, Last assessment in the 12-week Treatment Phase |
| Change From Baseline in Average Daily Interference With Sleep to the 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) | Baseline, Last 2 weeks of the 12-week Treatment Phase |
| Change From Baseline in Daily Interference With General Activity to the 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) | Baseline, Last 2 weeks of the 12-week Treatment Phase |
| Patient Global Impression of Change (PGIC) Assessment From Baseline to the 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]). | Baseline, Last assessment in the 12-week Treatment Phase |
| Change From Baseline in Morning and Evening Pain Scores to the 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). | Baseline, Last 2 weeks of the 12-week Treatment Phase |
| Number of Subjects Using Rescue Medication and Alcohol During the 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. | 12-week Treatment Phase |
| Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12 | End of the Maintenance Phase/Week 12 |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the 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. | Baseline, Last assessment in the 12-week Treatment Phase |
| Change From Baseline in Fibromyalgia Symptom Scores to the 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. | Baseline, Last assessment in the 12-week Treatment Phase |
| Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the 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. | Baseline, Last assessment in the 12-week Treatment Phase |
| Number of Subjects With Presence of Impulse Control Disorders | 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). | 12-week Treatment Phase |
| Mesa |
| Arizona |
| United States |
| Peoria | Arizona | 85381 | United States |
| Santa Ana | California | 92705 | United States |
| Cromwell | Connecticut | 06416 | United States |
| DeLand | Florida | 32720 | United States |
| Fort Myers | Florida | United States |
| Gainesville | Florida | 32611 | United States |
| Ocala | Florida | United States |
| Orlando | Florida | 32806 | United States |
| Palm Beach | Florida | United States |
| Sunrise | Florida | United States |
| Tampa | Florida | 33606 | United States |
| Columbia | Maryland | United States |
| Springfield | Massachusetts | 01103 | United States |
| St Louis | Missouri | 63141 | United States |
| Stratford | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| New York | New York | 10022 | United States |
| Rochester | New York | United States |
| Williamsville | New York | United States |
| Charlotte | North Carolina | United States |
| Raleigh | North Carolina | 27612 | United States |
| Cleveland | Ohio | 44122 | United States |
| Dayton | Ohio | 45408 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Portland | Oregon | United States |
| Souderton | Pennsylvania | United States |
| Crossville | Tennessee | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Bountiful | Utah | United States |
| Woodstock | Vermont | 05091 | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | 98104 | United States |
| Rotigotine 8 mg |
Rotigotine 8 mg/24 hrs |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | Rotigotine 4 mg | Rotigotine 4 mg/24 hrs |
| BG002 | Rotigotine 8 mg | Rotigotine 8 mg/24 hrs |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced). | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Last 2 weeks of the 12-week Treatment Phase |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the 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 | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Last assessment in the 12-week Treatment Phase |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Myalgic Score to the 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. | 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. | Posted | Baseline, Last assessment in the 12-week Treatment Phase |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Daily Interference With Sleep to the 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) | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Last 2 weeks of the 12-week Treatment Phase |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Daily Interference With General Activity to the 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) | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Last 2 weeks of the 12-week Treatment Phase |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Change (PGIC) Assessment From Baseline to the 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]). | 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. | Posted | Number | Patients | Baseline, Last assessment in the 12-week Treatment Phase |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning and Evening Pain Scores to the 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). | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Last 2 weeks of the 12-week Treatment Phase |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Using Rescue Medication and Alcohol During the 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. | 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. | Posted | 12-week Treatment Phase |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12 | 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. | Posted | Mean | Standard Deviation | ug/ML | End of the Maintenance Phase/Week 12 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the 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. | 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. | Posted | Baseline, Last assessment in the 12-week Treatment Phase |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fibromyalgia Symptom Scores to the 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. | 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. | Posted | Baseline, Last assessment in the 12-week Treatment Phase |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the 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. | 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. | Posted | Baseline, Last assessment in the 12-week Treatment Phase |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Presence of Impulse Control Disorders | 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). | 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. | Posted | 12-week Treatment Phase |
| ||||||||||||||||||||||||||||||||||||
| Primary | 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) | The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Last 2 weeks of the 12-week Treatment Phase |
|
|
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The Safety Set (SS) is comprised of all subjects who received at least 1 dose of trial medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo | 4 | 82 | 53 | 82 | ||
| EG001 | Rotigotine 4 mg | Rotigotine 4 mg/24 hrs | 1 | 73 | 55 | 73 | ||
| EG002 | Rotigotine 8 mg | Rotigotine 8 mg/24 hrs | 1 | 74 | 65 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Lung injury | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C047508 | rotigotine |
Not provided
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
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| Participants |
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| Units | Counts |
|---|
| Participants |
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