Fibromyalgia Syndrome
Conditions
Keywords
Fibromyalgia Syndrome, Rotigotine, Neupro
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.
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.
Interventions
DRUGRotigotine
Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch)
OTHERPlacebo
Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 \[score of 7\]). |
| 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). |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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). |
| Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12 | End of the Maintenance Phase/Week 12 | — |
| 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. |
Countries
United States
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 details
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
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo | 82 |
| Rotigotine 4 mg Rotigotine 4 mg/24 hrs | 73 |
| Rotigotine 8 mg Rotigotine 8 mg/24 hrs | 74 |
| Total | 229 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 12 | 17 | 33 |
| Overall Study | Lack of Efficacy | 7 | 7 | 4 |
| Overall Study | Lost to Follow-up | 5 | 2 | 5 |
| Overall Study | Non-compliance | 0 | 1 | 1 |
| Overall Study | Other: Personal family reasons | 0 | 0 | 1 |
| Overall Study | Other: Study demands too great | 0 | 1 | 0 |
| Overall Study | Other: Subject left town; family illness | 1 | 0 | 0 |
| Overall Study | Other: Subject's disability per sponsor | 0 | 0 | 1 |
| Overall Study | Other: Subject's schedule doesn't permit | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 5 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 5 |
Baseline characteristics
| Characteristic | Placebo | Total | Rotigotine 8 mg | Rotigotine 4 mg |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants | 227 Participants | 73 Participants | 73 Participants |
| Age, Continuous | 46.4 years STANDARD_DEVIATION 10.7 | 47.0 years STANDARD_DEVIATION 10.8 | 47.0 years STANDARD_DEVIATION 11.6 | 47.5 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 82 participants | 229 participants | 74 participants | 73 participants |
| Sex: Female, Male Female | 76 Participants | 209 Participants | 68 Participants | 65 Participants |
| Sex: Female, Male Male | 6 Participants | 20 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 53 / 82 | 55 / 73 | 65 / 74 |
| serious Total, serious adverse events | 4 / 82 | 1 / 73 | 1 / 74 |
Outcome results
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).
Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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) | -1.12 Score on a scale | Standard Deviation 1.83 |
| Rotigotine 4 mg | 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) | -1.27 Score on a scale | Standard Deviation 1.86 |
| Rotigotine 8 mg | 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) | -0.83 Score on a scale | Standard Deviation 1.7 |
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).
Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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) | -1.28 score on a scale | Standard Deviation 1.79 |
| Rotigotine 4 mg | 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) | -2.09 score on a scale | Standard Deviation 2.07 |
| Rotigotine 8 mg | 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) | -1.57 score on a scale | Standard Deviation 2.27 |
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)
Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase | -0.95 Score on a scale | Standard Deviation 2.01 |
| Rotigotine 4 mg | Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase | -0.82 Score on a scale | Standard Deviation 2.03 |
| Rotigotine 8 mg | Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase | -0.48 Score on a scale | Standard Deviation 2.09 |
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.
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Population: 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.
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)
Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase | -1.11 Score on a scale | Standard Deviation 2.05 |
| Rotigotine 4 mg | Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase | -1.19 Score on a scale | Standard Deviation 1.82 |
| Rotigotine 8 mg | Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase | -0.88 Score on a scale | Standard Deviation 2.1 |
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
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase | -14.9 Score on a scale | Standard Deviation 15.6 |
| Rotigotine 4 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase | -13.4 Score on a scale | Standard Deviation 13.7 |
| Rotigotine 8 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase | -12.8 Score on a scale | Standard Deviation 18.1 |
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.
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Population: 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.
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.
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Population: 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.
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).
Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase | Evening Pain Score | -1.17 Score on a scale | Standard Deviation 1.82 |
| Placebo | Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase | Morning Pain Score | -1.07 Score on a scale | Standard Deviation 1.91 |
| Rotigotine 4 mg | Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase | Morning Pain Score | -1.30 Score on a scale | Standard Deviation 1.91 |
| Rotigotine 4 mg | Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase | Evening Pain Score | -1.24 Score on a scale | Standard Deviation 1.9 |
| Rotigotine 8 mg | Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase | Morning Pain Score | -0.78 Score on a scale | Standard Deviation 1.78 |
| Rotigotine 8 mg | Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase | Evening Pain Score | -0.88 Score on a scale | Standard Deviation 1.89 |
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.
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Population: 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.
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.
Time frame: 12-week Treatment Phase
Population: 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.
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).
Time frame: 12-week Treatment Phase
Population: 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.
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 \[score of 7\]).
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Moderately worse | 7 Patients |
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Mildly better | 25 Patients |
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Much better | 8 Patients |
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Much worse | 1 Patients |
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Mildly worse | 5 Patients |
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | No change | 16 Patients |
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Moderately better | 14 Patients |
| Rotigotine 4 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Mildly better | 12 Patients |
| Rotigotine 4 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | No change | 17 Patients |
| Rotigotine 4 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Mildly worse | 3 Patients |
| Rotigotine 4 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Moderately worse | 1 Patients |
| Rotigotine 4 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Much worse | 1 Patients |
| Rotigotine 4 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Much better | 10 Patients |
| Rotigotine 4 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Moderately better | 14 Patients |
| Rotigotine 8 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | No change | 12 Patients |
| Rotigotine 8 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Much better | 9 Patients |
| Rotigotine 8 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Mildly worse | 5 Patients |
| Rotigotine 8 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Mildly better | 11 Patients |
| Rotigotine 8 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Moderately better | 7 Patients |
| Rotigotine 8 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Much worse | 2 Patients |
| Rotigotine 8 mg | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Moderately worse | 5 Patients |
Secondary
Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12
Time frame: End of the Maintenance Phase/Week 12
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine 4 mg | Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12 | 0.2388 ug/ML | Standard Deviation 0.2337 |
| Rotigotine 8 mg | Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12 | 0.2981 ug/ML | Standard Deviation 0.2973 |