At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 420 enrolled
Drug / intervention
SPM 962 +2 moredrug
Likely dose
SPM 962 36.0 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 Double-Blind, 3-Arm, Parallel Group, Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
In Brief
A Phase 3 clinical trial evaluating SPM 962, Ropinirole, and 1 other intervention for Parkinson's Disease. Completed, enrolled 420 participants across 8 sites.
Detailed Summary
* To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962. * To demonstrate the superiority of SPM 962 to placebo in terms of efficacy. * To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
Primary CompletionMay 2011
First PostedJun 2012
TodayJul 2026
First PostedJun 27, 2012
Enrollment StartJun 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.0 years ago
Interventions
SPM 962drug
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropiniroledrug
Ropinirole oral administration TID up to 15.0 mg/day
Placebodrug
SPM962-placebo patch and Ropinirole-placebo tab