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The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week, double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003). The trial is also for an exploratory investigation of incidence of augmentation, the most problematic complications in dopaminergic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPM 962 | Experimental | Rotigotine transdermal patch |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPM 962 | Drug | Tansdermal patch |
|
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| Measure | Description | Time Frame |
|---|---|---|
| The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters | The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of adverse events, vital signs, and laboratory parameters. AEs of special interest (1-3) are defined as below:
| Up to 54 weeks |
| Augmentation | Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity. Augmentation is clinically significant when at least one of the following occurs:
| Up to 53 weeks |
| Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit | 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. | Baseline, Up to 53 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of IRLS Sum Score From the Baseline to Each Visit | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23103551 | Derived | Inoue Y, Hirata K, Hayashida K, Hattori N, Tomida T, Garcia-Borreguero D; Rotigotine Study Group. Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome. Prog Neuropsychopharmacol Biol Psychiatry. 2013 Jan 10;40:326-33. doi: 10.1016/j.pnpbp.2012.10.012. Epub 2012 Oct 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SPM 962 | Rotigotine transdermal patch A patch containing 2.25 - 6.75mg of rotigotine was administered once a day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SPM 962 | Rotigotine transdermal patch |
| 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 | The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters | The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of adverse events, vital signs, and laboratory parameters. AEs of special interest (1-3) are defined as below:
| Safety set (SS) | Posted | Number | participants | Up to 54 weeks |
|
|
53 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 | SPM 962 | Rotigotine transdermal patch |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (11.1)J | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal 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. | +81-6361-7366 |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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| Baseline, Up to 53 weeks |
| Efficacy Rate in IRLS Sum Score | Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score. | Baseline, Up to 53 weeks |
| Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit | ASRS is a scale for assessing severity of augmentation. ASRS consists of 3 items (one item containing 4 sub-items). The sum of the score of each question serves as the scale score (each question score: 0-3, sum score 0-24). A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement. | Baseline, Up to 52 weeks |
| Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit | 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, Up to 53 weeks |
| Protocol Violation |
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| Discontinuation criteria |
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| Lost to Follow-up |
|
| Physician Decision |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Augmentation | Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity. Augmentation is clinically significant when at least one of the following occurs:
| SS | Posted | Number | participants | Up to 53 weeks |
|
|
|
| Secondary | Change of IRLS Sum Score From the Baseline to Each Visit | 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, Up to 53 weeks |
|
|
|
| Secondary | Efficacy Rate in IRLS Sum Score | Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score. | FAS, LOCF | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Up to 53 weeks |
|
|
|
| Secondary | Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit | ASRS is a scale for assessing severity of augmentation. ASRS consists of 3 items (one item containing 4 sub-items). The sum of the score of each question serves as the scale score (each question score: 0-3, sum score 0-24). A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Up to 52 weeks |
|
|
|
| Primary | Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit | 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. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Up to 53 weeks |
|
|
|
| Secondary | Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit | 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, Up to 53 weeks |
|
|
|
| 5 |
| 185 |
| 165 |
| 185 |
| Diverticulitis Intestinal Haemorrhagic | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Application Site Discolouration | General disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1)J | Non-systematic Assessment |
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| Neck Crushing | Injury, poisoning and procedural complications | MedDRA (11.1)J | Non-systematic Assessment |
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| Nerve Root Injury Lumbar | Injury, poisoning and procedural complications | MedDRA (11.1)J | Non-systematic Assessment |
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| Traffic Accident | Injury, poisoning and procedural complications | MedDRA (11.1)J | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Application Site Reaction | General disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Application Site Pruritus | General disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Application Site Erythema | General disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (11.1)J | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (11.1)J | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (11.1)J | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1)J | Non-systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (11.1)J | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Somnolence | Psychiatric disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
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| Week 44 |
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| Week 44 |
|
| Title | Measurements |
|---|---|
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| Week 44 |
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| Title |
|---|
| Measurements |
|---|
|
| Title | Measurements |
|---|---|
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| General health |
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| Vitality |
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| Social functioning |
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| Role emotional |
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