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

NCT00462254 | Terminated Phase 4

• 1 other identifier: #789
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Ramelteon; Parkinson's disease; Sleep disturbances

Outcome Measures

Primary Outcomes (3)

• Neuropsychiatric Inventory with Caregiver Distress (NPI-D) Sleep Behavior Subscale

  One and one-half years

• The Epworth Sleepiness Scale

  One and one-half years

• Sleep Disorders Questionnaire (short form)

  One and one-half years

Secondary Outcomes (4)

• Memory - Hopkins Verbal Learning Test (HVLT)

  One and one-half years

• Movement - Abnormal Involuntary Movement Scale (AIMS)

  One and one-half years

• Movement - Unified Parkinson's Disease Rating Scale (UPDRS)

  One and one-half years

• Movement - Continuous motor activity (actigraphy/motion logger)

  One and one-half years

Study Arms (2)

A

OTHER

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

B

OTHER

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

Interventions

ROZEREM DRUG

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

Also known as: Ramelteon

A

Ramelteon DRUG

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

Also known as: Rozerem

B

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern California Institute for Research and Education: lead

Study Sites (1)

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

Related Links

• Southern California Institute for Research and Education website

MeSH Terms

Conditions

Parkinson Disease; Parasomnias

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Wake Disorders; Mental Disorders

Study Officials

• Andrius Baskys, M.D.

  VA Long Beach Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: June 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 11, 2010

Record last verified: 2010-11

Locations

US (1)