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Effects of Rasagiline on Sleep Disturbances in Parkinson's Disease

NCT01442610 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-01-21

No results posted yet for this study

Summary

As the MAO-B inhibitor rasagiline is able to improve motor skills it might have positive effects on sleep disruption by reducing nocturnal akinesia. As it was reported to cause only minor sleep disruption in PD Patients, it might be able to improve sleep architecture. The investigators thus study the effects of Rasagiline on sleep disturbances measured by polysomnographic (PSG) evaluation of sleep efficacy and PDSS-2. Secondary measures are other sleep variables measured by PSG, sleep quality and daytime sleepiness assessed by standardized scales as well as cognitive function, depression and QoL index.

Conditions

Interventions

DRUG

Rasagiline

Rasagiline tablets 1mg once daily for 8 weeks

DRUG

Placebo

Placebo 1tablet once daily for 8 weeks

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    collaborator INDUSTRY

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Alexander Storch, MD · Dresden University of Technology, Dept. of Neurology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-03-31
Completion
2015-09-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01442610 on ClinicalTrials.gov