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

NCT ID: NCT01032486

Last Updated: 2013-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-07-31

Brief Summary

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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

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Conditions

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Parkinson's Disease

Keywords

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Rasagiline Sleep Sleepiness Parkinson's Disease Sleep Scale Epworth Sleepiness Scale

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Rasagiline mesylate

Intervention Type DRUG

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

Interventions

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Rasagiline mesylate

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

Intervention Type DRUG

Other Intervention Names

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Rasagiline mesylate, Azilect

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Panisset, MD

Role: PRINCIPAL_INVESTIGATOR

André Barbeau Movement Disorders Unit, Centre Hospitalier Université de Montréal (CHUM)

Countries

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Canada

Other Identifiers

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REST

Identifier Type: OTHER

Identifier Source: secondary_id

TNC-RAS-PD/01

Identifier Type: -

Identifier Source: org_study_id