A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome (RLS)
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Long-term Extension Trial From Late Phase II of SPM 962 (243-07-003) in Patients With Restless Legs Syndrome|
- The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters [ Time Frame: Up to 54 weeks ] [ Designated as safety issue: Yes ]
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:
- sudden onset of sleep
- obsessive-compulsive disorder or impulse-control disorder
- hallucination, delusion
- Augmentation [ Time Frame: Up to 53 weeks ] [ Designated as safety issue: Yes ]
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:
- Change in daily activities and/or behavior (e.g., the patient stops riding in cars in the afternoon) due to augmentation;
- Negative impact on the patient's quality of life (sleep, mood, etc.) due to augmentation;
- Need to change the treatment dose or the patienｔ needs to take the dose earlier in the day (e.g., dividing the dose);
- Adjustments in concomitant medication are made to compensate for augmented RLS symptoms (e.g., an increased intake of analgesics or hypnotics to cover an increase in symptom intensity);
- Any other aspect as judged by the evaluator (should be specified).
- Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit [ Time Frame: Baseline, Up to 53 weeks ] [ Designated as safety issue: No ]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.
- Change of IRLS Sum Score From the Baseline to Each Visit [ Time Frame: Baseline, Up to 53 weeks ] [ Designated as safety issue: No ]
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.
- Efficacy Rate in IRLS Sum Score [ Time Frame: Baseline, Up to 53 weeks ] [ Designated as safety issue: No ]Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.
- Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit [ Time Frame: Baseline, Up to 52 weeks ] [ Designated as safety issue: No ]
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.
- Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit [ Time Frame: Baseline, Up to 53 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: SPM 962
Rotigotine transdermal patch
Drug: SPM 962
Other Name: rotigotine