At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 174 enrolled

Drug / intervention

SPM 962 +1 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.

Search/NCT01628848

NCT01628848Phase 2Completed

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A Placebo-controlled Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Jun 27, 2012·Updated Mar 19, 2014

In Brief

A Phase 2 clinical trial evaluating SPM 962 and Placebo for Parkinson's Disease. Completed, enrolled 174 participants across 7 sites.

Detailed Summary

The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also to be investigated with distribution of the maintenance dose and accumulated response rate of efficacy.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsParkinson's Disease

CountriesJapan

Collaborators--

Timeline

Phase 2CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2006

Primary CompletionApr 2008

First PostedJun 2012

TodayJul 2026

First PostedJun 27, 2012

Enrollment StartAug 1, 2006

Primary CompletionApr 1, 2008

TodayJul 2, 2026

Enrollment to primary: 1.7 yearsPosted 14.0 years ago

Interventions

SPM 962drug

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

Placebodrug

Placebo transdermal patch