Parkinson's Disease Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease (PD)
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
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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