Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's Disease

Teva Branded Pharmaceutical Products R&D, Inc.120 enrolled

Overview

The main objective of this study is to evaluate the effect of Azilect® on sleep disturbances in Parkinson's Disease patients, after 2 months of treatment.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Parkinson's Disease

Interventions

Rasagiline mesylateDRUG

Azilect® tablets (0.5mg or 1.0 mg) administered orally once daily

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * idiopathic Parkinson's disease. * eligible to Azilect® treatment as per Canadian product monograph Exclusion Criteria: * exclusion (e.g. drug-drug interactions, contraindications, warnings and precautions) based on the Canadian product monograph. * investigational drug within 30 days prior to study * use of Azilect® or selegiline within 60 days prior to study * significant medical condition

Outcomes

Primary Outcomes

Change from baseline to end of the study in sleep disturbances as measured with the Parkinson's Disease Sleep Scale (PDSS).

Time frame: 2 months

Secondary Outcomes

Change from baseline to end of the study in daytime sleepiness as measured with the Epworth Sleepiness Scale (ESS).

Time frame: 2 months

Data from ClinicalTrials.gov

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