Overview

Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease

Status:
Terminated

Trial end date:
2012-10-01

Target enrollment:

Participant gender:

Summary

Sleep-wake disturbances (SWD) are frequent in Parkinson's disease (PD) and affect the quality of life of affected patients. Rasagiline is a potent, highly selective, irreversible, second-generation, monoamine oxidase type-B (MAO-B) inhibitor with a 24h dopaminergic effect. It is well known that dopaminergic treatment closely interacts with SWD. This study aims to assess the effect of Rasagiline on SWD in PD patients. In this randomized, double-blind, placebo controlled study in clinical phase IV, 60 subjects will be treated with rasagiline 1mg po once daily or placebo over 8 weeks. The study is planned to be conducted in 6-9 Swiss centers. Questionaires will be used to assess SWDs: sleep disturbances (Parkinson's Disease Sleep Scale, PDSS), daytime sleepiness (Epworth Sleepiness Scale, ESS), fatigue (Fatigue Severity Scale, FSS), apathy (Apathy Evaluation Scale Self, AES-S), disability (Sheehan scale) and QoL in PD patients. - Trial with medicinal product

Phase:

Phase 4

Details

Lead Sponsor:

University of Zurich

Collaborator:

H. Lundbeck A/S

Treatments:

Rasagiline