drugset / Trial / NCT00666965

A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients

NCT00666965

Phase 2 Completed 230 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 Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple transdermal doses of SPM 962 within a range of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.

Timeline

Start
2008-06
Primary completion
2009-08
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Rotigotine Unknown 2.25 mg Other
Subject Rotigotine Unknown 4.5 mg Other
Subject Rotigotine Unknown 6.75 mg Other