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

An Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease Subjects

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 Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Rasagiline mesylate

• Study Type: Observational
• Enrollment (Actual): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is a sample of participants with Parkinson's disease who will be prescribed Azilect® treatment as per Canadian product monograph in order to observe changes in sleep behaviour.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Azilect; 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.	Drug: Rasagiline mesylate; Azilect® tablets (0.5mg or 1.0 mg) administered orally once daily; Other Names: Rasagiline mesylate, Azilect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Principal Investigator: Michel Panisset, MD, André Barbeau Movement Disorders Unit, Centre Hospitalier Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: December 11, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): August 28, 2013
• Last Update Submitted That Met QC Criteria: August 27, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Sleep; Sleepiness; Epworth Sleepiness Scale; Rasagiline; Parkinson's Disease Sleep Scale
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Monoamine Oxidase Inhibitors; Rasagiline
• Other Study ID Numbers: TNC-RAS-PD/01; REST (Teva)