At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 180 enrolled
Drug / intervention
SPM 962 +1 moredrug
Likely dose
Not stated in 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 Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa
In Brief
A Phase 3 clinical trial evaluating SPM 962 and placebo for Early Parkinson's Disease. Completed, enrolled 180 participants across 6 sites.
Detailed Summary
To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Parkinson's Disease
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedOct 2007
Primary CompletionDec 2009
TodayJul 2026
First PostedOct 1, 2007
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.8 years ago
Interventions
SPM 962drug
transdermal application, 1 time per day
placebodrug
transdermal application, 1 time per day