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Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease

NCT00462254 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2010-11-11

No results posted yet for this study

Summary

Patients with Parkinson's disease represent a significant proportion of VA elderly patients. Sleep disturbances and caregiver burnout association with this condition represent a significant problem. In this study, the investigators propose to perform an evaluation of a fixed doe of ramelteon on sleep in VA outpatients diagnosed with Parkinson's disease.

The hypothesis to be examined is that ramelteon will improve the quality of sleep in patients with Parkinson's disease while indirectly improving the quality of life for the patients and caregivers. The investigators further hypothesize that these changes will occur through restructuring and normalization of the sleep architecture.

Conditions

Interventions

DRUG

ROZEREM

8 mg tablet orally 30 minutes before bedtime for 8 days (Days 4-11).

DRUG

Ramelteon

8 mg tablet orally 30 minutes before bedtime for 8 days (Days 15-22).

Sponsors & Collaborators

  • Southern California Institute for Research and Education

    lead OTHER

Principal Investigators

  • Andrius Baskys, M.D. · VA Long Beach Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00462254 on ClinicalTrials.gov