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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
185
Tansdermal patch
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: 1. sudden onset of sleep 2. obsessive-compulsive disorder or impulse-control disorder 3. hallucination, delusion
Time frame: 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: 1. Change in daily activities and/or behavior (e.g., the patient stops riding in cars in the afternoon) due to augmentation; 2. Negative impact on the patient's quality of life (sleep, mood, etc.) due to augmentation; 3. Need to change the treatment dose or the patient needs to take the dose earlier in the day (e.g., dividing the dose); 4. 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); 5. Any other aspect as judged by the evaluator (should be specified).
Time frame: 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.
Time frame: Baseline, Up to 53 weeks
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.
Time frame: Baseline, Up to 53 weeks
Efficacy Rate in IRLS Sum Score
Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Up to 53 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.