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

Primary Purpose

Parkinson's Disease

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ROZEREM
Ramelteon
Sponsored by
Southern California Institute for Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Ramelteon, Parkinson's disease, Sleep disturbances

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Long Beach Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A

B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Neuropsychiatric Inventory with Caregiver Distress (NPI-D) Sleep Behavior Subscale
The Epworth Sleepiness Scale
Sleep Disorders Questionnaire (short form)

Secondary Outcome Measures

Memory - Hopkins Verbal Learning Test (HVLT)
Movement - Abnormal Involuntary Movement Scale (AIMS)
Movement - Unified Parkinson's Disease Rating Scale (UPDRS)
Movement - Continuous motor activity (actigraphy/motion logger)

Full Information

First Posted
April 16, 2007
Last Updated
November 10, 2010
Sponsor
Southern California Institute for Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT00462254
Brief Title
Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease
Official Title
Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
Study discontinued.
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Southern California Institute for Research and Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Ramelteon, Parkinson's disease, Sleep disturbances

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
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.
Arm Title
B
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ROZEREM
Other Intervention Name(s)
Ramelteon
Intervention Description
8 mg tablet orally 30 minutes before bedtime for 8 days (Days 4-11).
Intervention Type
Drug
Intervention Name(s)
Ramelteon
Other Intervention Name(s)
Rozerem
Intervention Description
8 mg tablet orally 30 minutes before bedtime for 8 days (Days 15-22).
Primary Outcome Measure Information:
Title
Neuropsychiatric Inventory with Caregiver Distress (NPI-D) Sleep Behavior Subscale
Time Frame
One and one-half years
Title
The Epworth Sleepiness Scale
Time Frame
One and one-half years
Title
Sleep Disorders Questionnaire (short form)
Time Frame
One and one-half years
Secondary Outcome Measure Information:
Title
Memory - Hopkins Verbal Learning Test (HVLT)
Time Frame
One and one-half years
Title
Movement - Abnormal Involuntary Movement Scale (AIMS)
Time Frame
One and one-half years
Title
Movement - Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame
One and one-half years
Title
Movement - Continuous motor activity (actigraphy/motion logger)
Time Frame
One and one-half years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrius Baskys, M.D.
Organizational Affiliation
VA Long Beach Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.scire-lb.org
Description
Southern California Institute for Research and Education website

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

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