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

Parkinson's Disease Clinical Trial

— PD  

Official title:

An Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032486
• Other study ID #: TNC-RAS-PD/01
• Secondary ID: REST
• Status: Completed
• Phase: Phase 4
• First received: December 11, 2009
• Last updated: August 27, 2013
• Start date: December 2009
• Est. completion date: July 2011

Study information

• Verified date: August 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rasagiline mesylate
Azilect® tablets (0.5mg or 1.0 mg) administered orally once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to end of the study in sleep disturbances as measured with the Parkinson's Disease Sleep Scale (PDSS).		2 months	No
Secondary	Change from baseline to end of the study in daytime sleepiness as measured with the Epworth Sleepiness Scale (ESS).		2 months	No