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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: August 27, 2013
Last verified: August 2013

December 11, 2009
August 27, 2013
December 2009
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01032486 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's Disease
An Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease Subjects

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Parkinson's Disease
Drug: Rasagiline mesylate
Azilect® tablets (0.5mg or 1.0 mg) administered orally once daily
Other Name: Rasagiline mesylate, Azilect
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.
Intervention: Drug: Rasagiline mesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
July 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01032486
TNC-RAS-PD/01, REST
No
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Principal Investigator: Michel Panisset, MD André Barbeau Movement Disorders Unit, Centre Hospitalier Université de Montréal (CHUM)
Teva Pharmaceutical Industries
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP