CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 321 enrolled
Drug / intervention
SPM 962drug
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.

Search/NCT01631825
NCT01631825Phase 3Completed
CompareCT.gov

An Open-label Long-term Extension Trial From Phase III of SPM962 (243-08-002) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Jun 29, 2012·Updated Mar 19, 2014

In Brief

A Phase 3 clinical trial evaluating SPM 962 for Parkinson's Disease. Completed, enrolled 321 participants across 8 sites.

Detailed Summary

* To investigate the safety of once-daily repeated transdermal administration of SPM 962 within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label uncontrolled study. * To investigate efficacy of SPM 962 in an exploratory manner.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 29, 2012
Enrollment StartOct 1, 2009
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.0 years ago

Interventions

SPM 962drug

SPM 962 transdermal patch once a daily up to 36.0 mg/day