At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 230 enrolled
Drug / intervention
SPM 962drug
Likely dose
SPM 962 6.75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Placebo-Controlled Study for SPM 962 in RLS Patients
In Brief
A Phase 2 clinical trial evaluating SPM 962 for Idiopathic Restless Legs Syndrome. Completed, enrolled 230 participants across 8 sites.
Detailed Summary
The primary objective of this study is to investigate efficacy and safety of SPM 962 in Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple transdermal doses of SPM 962 within a range of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Restless Legs Syndrome
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartJun 2008
Primary CompletionAug 2009
TodayJul 2026
First PostedApr 25, 2008
Enrollment StartJun 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.2 years ago
Interventions
SPM 962drug
transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks