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: August 27, 2013
Last verified: August 2013
  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: Observational
Study Design: 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

Resource links provided by NLM:


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)
Groups/Cohorts 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 27, 2013
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 July 22, 2014