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

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ClinicalTrials.gov Identifier: NCT01032486
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Rasagiline mesylate Phase 4

Study Design

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease Subjects
Study Start Date : December 2009
Primary Completion Date : June 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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 Name: Rasagiline mesylate, Azilect


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline to end of the study in daytime sleepiness as measured with the Epworth Sleepiness Scale (ESS). [ Time Frame: 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032486


Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Michel Panisset, MD André Barbeau Movement Disorders Unit, Centre Hospitalier Université de Montréal (CHUM)
More Information

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01032486     History of Changes
Other Study ID Numbers: TNC-RAS-PD/01
REST ( Other Identifier: Teva )
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013

Keywords provided by Teva Pharmaceutical Industries:
Rasagiline
Sleep
Sleepiness
Parkinson's Disease Sleep Scale
Epworth Sleepiness Scale

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs