A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome (RLS)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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 ]
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 ]
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 ]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 ]
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 ]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 ]
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 ]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