Study for Rasagiline Effect on Sleep Trial(REST)in Parkin... | NCT01032486

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

NCT01032486

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Status

Completed

Last Update Posted

Aug 28, 2013Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Parkinson's Disease

Interventions

Rasagiline mesylate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
REST	Other Identifier	Teva

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Dec 11, 2009

First Submission Date that Met QC Criteria

Dec 14, 2009

First Posted Date

Dec 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2013

Last Update Posted Date

Aug 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rasagiline mesylate	Drug	Azilect® tablets (0.5mg or 1.0 mg) administered orally once daily	Azilect

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michel Panisset, MD	André Barbeau Movement Disorders Unit, Centre Hospitalier Université de Montréal (CHUM)	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D000077260	Sleepiness

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C031967	rasagiline

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided