NCT01032486

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

1.5 years

First QC Date

December 11, 2009

Last Update Submit

August 27, 2013

Conditions

Parkinson's Disease

Keywords

RasagilineSleepSleepinessParkinson's Disease Sleep ScaleEpworth Sleepiness Scale

Outcome Measures

Primary Outcomes (1)

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

    2 months

Secondary Outcomes (1)

  • Change from baseline to end of the study in daytime sleepiness as measured with the Epworth Sleepiness Scale (ESS).

    2 months

Study Arms (1)

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

Interventions

Rasagiline mesylateDRUG

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

Also known as: Rasagiline mesylate, Azilect
Azilect

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • idiopathic Parkinson's disease.
  • eligible to Azilect® treatment as per Canadian product monograph

You may not qualify if:

  • investigational drug within 30 days prior to study
  • use of Azilect® or selegiline within 60 days prior to study
  • significant medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson DiseaseSleepiness

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michel Panisset, MD

    André Barbeau Movement Disorders Unit, Centre Hospitalier Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2009

First Posted

December 15, 2009

Study Start

December 1, 2009

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

August 28, 2013

Record last verified: 2013-08