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The primary objective of this study is to investigate efficacy and safety of SPM 962 in Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple transdermal doses of SPM 962 within a range of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | inactive placebo |
|
| 2 | Experimental | 2.25 mg first week: 2.25 mg 1 sheet plus placebo 1 sheet 2nd to 6th week :2.25mg 1 sheet plus placebo 2 sheets |
|
| 3 | Experimental | 4.5 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 2 sheets pus placebo 1 sheet |
|
| 4 | Experimental | 6.75 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 3sheets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPM 962 | Drug | transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period | IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement. | Baseline, end of maintenance period at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression (CGI) Severity | CGI is a clinician-reported scale for assessing severity of illness. The sale scoring criteria are 1: Normal, not at all ill, 2: Borderline ill, 3: Mildly ill, 4: Moderately ill, 5: Markedly ill, 6: Severely ill, 7: Among the most extremely ill patients. | Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown. |
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Inclusion Criteria:
Subject is 20 and more and less than 80 years of age and is able to think about her/his participation at the time of informed consent.
Subject meets the diagnosis of idiopathic RLS based on the 4 cardinal clinical features according to the IRLSSG/NIH.
The following subject will be included in the study
At baseline, subject has a score of ≧ 15 on the IRLS sum score and RLS symptoms occur twice and more a week (≧score 2 in IRLS Question 7)
Subject has a score of ≧ 4 on the CGI Severity score at baseline
Exclusion Criteria:
19. Subject received an investigational drug from other clinical trial within the last 12 months prior to baseline.
20. Subject is judged to be inappropriate for this trial by investigator on the other than above.
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| Name | Affiliation | Role |
|---|---|---|
| Katsuhisa Saito | New Product Evaluation Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo transdermal patch |
| FG001 | 2.25 mg/Day | SPM962 maintein dose: 2.25 mg/day |
| FG002 | 4.5 mg/Day | SPM962 maintein dose: 4.5mg/day |
| FG003 | 6.75 mg/Day | SPM962 maintein dose: 6.75 mg/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
3 subjects (1 for each placebo, 4.5 mg/day and 6.75 mg/day arm) were excluded by criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo transdermal patch |
| BG001 | 2.25 mg/Day | SPM962 maintein dose: 2.25 mg/day |
| 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 |
| 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 of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period | IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement. | Full analysis set (FAS), last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | scores on a scale | Baseline, end of maintenance period at 6 weeks |
|
7 weeks
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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 transdermal patch |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research and Development | Otsuka Pharmaceutical Co., Ltd. | +81-3-6361-7366 |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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| Patient Global Impression (PGI) Improvement | The PGI-I is a self-rated 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Moderate and marked improvement = score of 1 or 2, Without improvement = score of 4, Marked and moderate aggravation = score of 6 or 7. | Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown. |
| The Pittsburgh Sleep Quality Index (PSQI) | PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates "no difficulty" and 21 indicates "severe difficulty". A decrease in the scores means improvement. The data at 6 weeks after dosing is shown. | Baseline, every two weeks |
| Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36) | Mean Change from baseline in MOS Short Form SF-36 to 6 weeks after dosing. SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement. | Baseline, every two weeks |
| IRLS Each Parameter | IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement. The percentage of subjects with -3 or -4 changes from baseline in each parameter at 6 weeks after dosing is shown. | Baseline, every two weeks |
| Chugoku Region |
| Japan |
| Hokkaido Region | Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Tohoku Region | Japan |
| Lack of Efficacy |
|
| Protocol Violation |
|
| Discontinuation criteria |
|
| Withdrawal by Subject |
|
| BG002 |
| 4.5 mg/Day |
SPM962 maintein dose: 4.5mg/day |
| BG003 | 6.75 mg/Day | SPM962 maintein dose: 6.75 mg/day |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 2.25 mg/Day | SPM962 maintein dose: 2.25 mg/day |
| OG002 | 4.5 mg/Day | SPM962 maintein dose: 4.5mg/day |
| OG003 | 6.75 mg/Day | SPM962 maintein dose: 6.75 mg/day |
|
|
| Secondary | Clinical Global Impression (CGI) Severity | CGI is a clinician-reported scale for assessing severity of illness. The sale scoring criteria are 1: Normal, not at all ill, 2: Borderline ill, 3: Mildly ill, 4: Moderately ill, 5: Markedly ill, 6: Severely ill, 7: Among the most extremely ill patients. | FAS, LOCF | Posted | Number | Percentage of Participants | Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown. |
|
|
|
| Secondary | Patient Global Impression (PGI) Improvement | The PGI-I is a self-rated 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Moderate and marked improvement = score of 1 or 2, Without improvement = score of 4, Marked and moderate aggravation = score of 6 or 7. | FAS, LOCF | Posted | Number | Percentage of Participants | Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown. |
|
|
|
| Secondary | The Pittsburgh Sleep Quality Index (PSQI) | PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates "no difficulty" and 21 indicates "severe difficulty". A decrease in the scores means improvement. The data at 6 weeks after dosing is shown. | FAS, LOCF | Posted | Number | Percentage of Participants | Baseline, every two weeks |
|
|
|
| Secondary | Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36) | Mean Change from baseline in MOS Short Form SF-36 to 6 weeks after dosing. SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, every two weeks |
|
|
|
| Secondary | IRLS Each Parameter | IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement. The percentage of subjects with -3 or -4 changes from baseline in each parameter at 6 weeks after dosing is shown. | FAS, LOCF | Posted | Number | Percentage of Participants | Baseline, every two weeks |
|
|
|
| 0 |
| 58 |
| 29 |
| 58 |
| EG001 | 2.25 mg/Day | SPM962 maintein dose: 2.25 mg/day | 0 | 57 | 37 | 57 |
| EG002 | 4.5 mg/Day | SPM962 maintein dose: 4.5mg/day | 0 | 58 | 50 | 58 |
| EG003 | 6.75 mg/Day | SPM962 maintein dose: 6.75 mg/day | 0 | 57 | 44 | 57 |
| Photopsia | Eye disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Stomach Discomfort | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Application Site Pruritus | General disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Application Site Reaction | General disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Application Site Erythema | General disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1)J | Non-systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (11.1)J | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Somnolence | Psychiatric disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Menses Irregular | Reproductive system and breast disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
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| Increased |
|
| Decreased to 1 or 2 |
|
| Subjects with CGI score 5 |
|
| Subjects without improvement |
|
| 4 at baseline and stayed at 4 |
|
| 5 at baseline and decreased to 1 or 2 |
|
| Without improvement |
|
| Moderate and marked aggravation |
|
| Subjects with ≥50% decrease |
|
| Role physical |
|
| Bodily pain |
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| General health |
|
| Vitality |
|
| Social functioning |
|
| Role emotional |
|
| -3 (RLS discomfort) |
|
| -4 (need to move around due to RLS symptoms) |
|
| -3 (need to move around due to RLS symptoms) |
|
| -4 (discomfort relief by moving around) |
|
| -3 (discomfort relief by moving around) |
|
| -4 (severity of RLS as a whole) |
|
| -3 (severity of RLS as a whole) |
|
| -4 (RLS symptoms frequency) |
|
| -3 (RLS symptoms frequency) |
|
| -4 (average duration of RLS symptoms) |
|
| -3 (average duration of RLS symptoms) |
|
| -4 (severity of sleep disturbance) |
|
| -3 (severity of sleep disturbance) |
|
| -4 (tiredness or sleepiness during the day) |
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| -3 (tiredness or sleepiness during the day) |
|
| -4 (severity of impact on daily affaires) |
|
| -3 (severity of impact on daily affaires) |
|
| -4 (severity of mood disturbance) |
|
| -3 (severity of mood disturbance) |
|