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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01032486

Acronym

Enrollment

120

Registered

2009-12-15

Start date

2009-12-31

Completion date

2011-07-31

Last updated

2013-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Rasagiline, Sleep, Sleepiness, Parkinson's Disease Sleep Scale, Epworth Sleepiness Scale

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.

Interventions

DRUGRasagiline mesylate

Azilect® tablets (0.5mg or 1.0 mg) administered orally once daily

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline to end of the study in sleep disturbances as measured with the Parkinson's Disease Sleep Scale (PDSS).	2 months

Secondary

Measure	Time frame
Change from baseline to end of the study in daytime sleepiness as measured with the Epworth Sleepiness Scale (ESS).	2 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026