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

November 10, 2010 updated by: Southern California Institute for Research and Education

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

It is well established that sleep disturbances are common in patients with neurodegenerative disorders such as Parkinson's disease. Together with psychosis and other behavioral abnormalities they contribute to the stress, anxiety and cognitive decline of patients, caregiver burnout and depression, as well as health care provider frustration. The mechanisms of the sleep disturbances in these conditions are still poorly understood and no rational or effective treatments have been proposed. Recent data from a study of ramelteon in the elderly showed a striking ability of this compound to improve quality of sleep disturbances in Parkinson's disease.

Objectives of this study are:

  • To examine the effects of ramelteon on the quality of sleep using sleep evaluation instruments (SDQ-Sleep Disorder Questionnaire and Neuropsychiatric Inventory with Caregiver Distress (NPI-D) Sleep Behavior Subscale administered to the patient and/or their bed partner.
  • To examine the effects of ramelteon on daytime sleepiness and memory using Epworth Sleepiness Scale (ESS) and Hopkins Verbal Learning Test (HVLT).
  • To examine the effects of ramelteon on the sleep/wake cycle and day/night activity patterns over a prolonged period of time (1 week) using a motion logger (continuous motor activity recording device) and computerized data analysis.
  • To examine the effects of ramelteon on sleep architecture in a sample of patients with confirmed sleep disturbance, before and after ramelteon treatment by using polysomnography.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 45-85 years of age and living in the community
  • Male or female of non-child bearing potentials (non-child bearing is defined as at lease 6 months post-menopause or surgically sterile)
  • Must have a diagnosis of Parkinson's disease
  • Must have complaints of sleep disturbance

Exclusion Criteria:

  • Patients with diagnosis of or those meeting DSM-IV criteria for major depression, schizophrenia or schizoaffective disorder, bipolar disorder, substance abuse disorder, other mental illness that is known to contribute to sleep disturbance, epilepsy, other medical conditions that are known to cause or contribute to sleep disturbances
  • Patients currently using melatonin or ramelteon, hypnotics, benzodiazepines, antidepressants, blood-brain barrier permeable beta blockers, steroids, antipsychotics
  • Patients with clinically significant blood or urine abnormalities
  • Patients who have taken any investigational drug less than 1 month prior to the baseline visit
  • Patients with multiple concomitant disorders with or without medications thought to produce sleep disturbances
  • Patients with pre-existing sleep disturbances unrelated to Parkinson's disease
  • Patients with severe hepatic impairment (Child-Pugh Class C)
  • Patients with severe COPD (those with elevated pCO2 levels or those needing nocturnal oxygen therapy
  • Patients with severe sleep apnea
  • Patients who have sensitivity to ramelteon or any constituents of the Rozerem preparation
  • Patients taking rifampin or potent inducers of CYP1A2, CYP3A4, CYP2C9 (ketoconazole, fluconazole)
  • Patients living in a nursing home. Those living in assisted living facilities and board and care facilities may be included
  • Patients unable to comply with the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: A
Day 1-3: placebo run-in - 8 mg of placebo orally 30 minutes before bedtime. Days 4-11: true drug - 8 mg of Ramelteon orally 30 minutes before bedtime. Days 12-14: crossover - 8 mg of placebo orally 30 minutes before bedtime. Days 15-22: continue placebo.
Drug: ROZEREM
8 mg tablet orally 30 minutes before bedtime for 8 days (Days 4-11).
Other Names:
  • Ramelteon
OTHER: B
Day 1-3: Placebo run-in - 8 mg of placebo orally 30 minutes before bedtime. Days 4-11: continue placebo. Days 12-14: crossover - 8 mg of placebo orally 30 minutes before bedtime. Days 15-22: true drug - 8 mg of Ramelteon orally 30 minutes before bedtime.
Drug: Ramelteon
8 mg tablet orally 30 minutes before bedtime for 8 days (Days 15-22).
Other Names:
  • Rozerem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neuropsychiatric Inventory with Caregiver Distress (NPI-D) Sleep Behavior Subscale
Time Frame: One and one-half years
One and one-half years
The Epworth Sleepiness Scale
Time Frame: One and one-half years
One and one-half years
Sleep Disorders Questionnaire (short form)
Time Frame: One and one-half years
One and one-half years

Secondary Outcome Measures

Outcome Measure
Time Frame
Memory - Hopkins Verbal Learning Test (HVLT)
Time Frame: One and one-half years
One and one-half years
Movement - Abnormal Involuntary Movement Scale (AIMS)
Time Frame: One and one-half years
One and one-half years
Movement - Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: One and one-half years
One and one-half years
Movement - Continuous motor activity (actigraphy/motion logger)
Time Frame: One and one-half years
One and one-half years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California Institute for Research and Education

Investigators

  • Principal Investigator: Andrius Baskys, M.D., VA Long Beach Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

April 16, 2007

First Submitted That Met QC Criteria

April 17, 2007

First Posted (ESTIMATE)

April 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 11, 2010

Last Update Submitted That Met QC Criteria

November 10, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #789

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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