Trial intelligence / Profile preview

Rotigotine Patch in Advanced Parkinson's Disease (CLEOPATRA-PD)

NCT00244387Phase 3

Key facts

Status: Completed
Start: Mar 2004
Primary completion: Jul 2005
Countries: 1
Sponsor: UCB
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 UCB. Primary endpoint: Absolute change in total hours 'off' per day at 24 weeks. Started Mar 2004; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Rotigotine
Rotigotine patch titrated to optimal dose (up to 16 mg/24h)
Pramipexole
Pramipexole capsules titrated to optimal dose (up to 4.5 mg/day)
Placebo
Placebo patch and placebo capsules

Who it enrols

Patients with advanced stage idiopathic Parkinson's disease not well controlled on levodopa.

Endpoints

Primary

Absolute change in total hours 'off' per day24 weeks

Secondary

Responder rate (>=30% reduction in off time)24 weeks
Unified Parkinson's Disease Rating Scale Part III (Motor Score)24 weeks
On time without troublesome dyskinesia24 weeks

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