drugset / Trial / NCT01628848

A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients

NCT01628848

Phase 2 Completed 174 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2006-08
Primary completion
2008-04
Completion
2008-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Rotigotine Unknown 4.5 mg Other
Subject Rotigotine Unknown 36 mg Other

Indications