drugset / Trial / NCT01628926

A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients

NCT01628926

Phase 3 Completed 420 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-06
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ropinirole Small molecule 15 mg Oral
Subject Rotigotine Unknown 36 mg Other

Indications