Trial intelligence / Profile preview

SPM 962 (Rotigotine) vs Ropinirole in Advanced Parkinson's Disease

NCT01628926Phase 3

Key facts

Status: Completed
Start: Jun 2009
Primary completion: May 2011
Countries: 1
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Modality: Small Molecules

Drugs: rotigotine
Conditions: Parkinson's disease (PD)

Overview

Phase 3, randomised, double-blind trial of rotigotine in Parkinson's disease (PD) (3 arms), sponsored by Otsuka Pharmaceutical Co., Ltd. Primary endpoint: Unified Parkinson's Disease Rating Score Part 3 Sum Score at 16 weeks. Started Jun 2009; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

SPM 962
SPM 962 (Rotigotine) transdermal patch up to 36.0 mg/day + L-dopa
Ropinirole
Ropinirole tablet up to 15.0 mg/day + L-dopa
Placebo
Placebo patch and Placebo tablet + L-dopa

Who it enrols

Patients aged 30-80 with advanced Parkinson's disease (Hoehn & Yahr 2-4) on a stable dose of L-dopa, experiencing motor complications (wearing off, on-off, dyskinesia). Excludes patients with psychiatric symptoms, orthostatic hypotension, serious cardiac disease, or history of intolerance to ropinirole.

Endpoints

Primary

Unified Parkinson's Disease Rating Score Part 3 Sum Score16 weeks

Secondary

Unified Parkinson's Disease Rating Score Part 3 Sum Score10 weeks
Unified Parkinson's Disease Rating Score Part 2 Sum Score16 weeks
Off Time16 weeks
Parkinson's Disease Sleep Scale-216 weeks
On Time16 weeks
On Time Without Dyskinesia Disturbing Daily Activities16 weeks
On Time With Dyskinesia Disturbing Daily Activities16 weeks
Effective Rate in UPDRS Part 3 Sum Score16 weeks

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