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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleepiness Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rasagiline mesylate

Drug

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

Other names: Rasagiline mesylate, Azilect

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

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

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

Acronym: PD

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Dec 15, 2009
Registry last updated: Aug 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed