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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01032486
First received: December 11, 2009
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Parkinson's Disease
 Drug: Rasagiline mesylate
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to end of the study in daytime sleepiness as measured with the Epworth Sleepiness Scale (ESS). [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: December 2009
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01032486     History of Changes
Other Study ID Numbers: TNC-RAS-PD/01, REST
Study First Received: December 11, 2009
Last Updated: July 5, 2012
Health Authority: Canada: Health Canada

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
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013