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

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Rasagiline mesylate

• Registration Number: NCT01032486
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-27
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azilect	Rasagiline mesylate	Subjects with a diagnosis of idiopathic Parkinson's disease eligible to Azilect® treatment based on the investigator's clinical assessment and according to the Canadian product monograph.

Primary Outcome Measures

Name	Time	Method
Change from baseline to end of the study in sleep disturbances as measured with the Parkinson's Disease Sleep Scale (PDSS).	2 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline to end of the study in daytime sleepiness as measured with the Epworth Sleepiness Scale (ESS).	2 months