The objective of this study is to evaluate the clinical efficacy and safety of SPM962 in patients with restless legs syndrome (RLS) with once-daily repeated doses of 4.5mg and 6.75mg during a 13-week dose-titration and maintenance period. This is a multi-center, randomized, placebo-controlled, double-blind, 3-armed parallel group comparison study. Efficacy will be determined by investigating the superiority of SPM962 to placebo in terms of the primary efficacy variable, change in International Restless Legs Syndrome Rating Scale (IRLS) total score from baseline to the end of the dose-maintenance period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
284
once a daily transdermal administration started at 2.25 mg/day to 4.5 mg/day for 13 weeks
once a daily transdermal administration started at 2.25 mg/day to 6.75 mg/day for 13 weeks
once a daily transdermal administration for 13 weeks
Unnamed facility
Chubu Region, Japan
Unnamed facility
Chugoku Region, Japan
Unnamed facility
Hokkaido Region, Japan
Unnamed facility
Kansai Region, Japan
Unnamed facility
Kanto Region, Japan
Unnamed facility
Kyushu Region, Japan
Unnamed facility
Shikoku Region, Japan
Unnamed facility
Tohoku Region, Japan
International Restless Legs Syndrome Rating Scale (IRLS) Total Score
Change from the baseline to the end of dose-titration/dose-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.
Time frame: Baseline, the end of dose-titration/dose-maintenance period (week 13)
Clinical Global Impression (CGI) Improvement
CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline. The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse.
Time frame: Baseline, the end of dose-titration/dose-maintenance period (week 13)
Patient Global Impression (PGI) Improvement
PGI improvement is a patient-reported scale for assessing how much the patient's illness has improved or worsened from baseline. The scale scoring criteria are 1: very much better, 2: much better, 3: a little better, 4: no change, 5: a little worse, 6: much worse, 7: very much worse.
Time frame: Baseline, the end of dose-titration/dose-maintenance period (week 13)
The Pittsburgh Sleep Quality Index (PSQI)
Change of PSQI from baseline to the end of dose-titration/dose-maintenance period. 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, the end of dose-titration/dose-maintenance period (week 13)
Each Item of IRLS (10 Items)
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). Numbers of subjects with -4 or -3 score change from baseline in each item of IRLS. A decrease in the scores means improvement.
Time frame: Baseline, the end of dose-titration/dose-maintenance period (week 13)
Incidence of RLS Symptoms
Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms in the week / the number of evaluation days in the week\* 100%
Time frame: Baseline, the end of dose-titration/dose-maintenance period (week 13)
Average Duration of RLS Symptoms
Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.
Time frame: Baseline, the end of dose-titration/dose-maintenance period (weeks 13)
Incidence of RLS Symptoms in the Evening and Night
Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms / the number of days of evaluation \* 100%.
Time frame: Baseline, the end of dose-titration/dose-maintenance period (week 13)
Average Duration of RLS Symptoms in the Evening and Night in a Week
Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.
Time frame: Baseline, the end of dose-titration/dose-maintenance period (weeks 13)
Nocturnal Awakenings Due to RLS Symptoms in a Week
Nocturnal awakening rate is calculated as the number of days with nocturnal awakenings / the number of days of evaluation \* 100%.
Time frame: Baseline, the end of dose-titration/dose-maintenance period (week 13)
Average Sleep Time in a Week
Change of average sleep time in a week from baseline to the end of dose-titration/dose-maintenance period.
Time frame: Baseline, the end of dose-titration/dose-maintenance period (weeks 13)
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