Treating Sleep/Wake Cycle Disturbances in Basal Ganglia Disorders With Ramelteon

NCT00907595 | Withdrawn DMC

• 1 other identifier: 06-043R
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is a double-blind, placebo controlled pilot study of HD, PD, and DLB subjects with sleep disturbances. This study is designed to determine the effects of 4 weeks Ramelteon treatment on the sleep patterns of people with basal ganglia disorders such as HD, PD and DLB. The study also aims to look at the sleep patterns of caregivers of people with HD, PD and DLB.

Conditions

Huntington's Disease; Parkinson's Disease; Dementia With Lewy Bodies; Sleep Disorders; Circadian Dysregulation

Keywords

Huntington's chorea; Huntington's Disease; Parkinson's Disease; Parkinsonism; Dementia; Dementia with Lewy Bodies; Actigraphy; Circadian dysregulation; Sleep Disorders; Circadian rhythm

Outcome Measures

Primary Outcomes (1)

• Sleep efficiency and other actigraphy derived sleep parameters

  2 weeks pre intervention; 4 weeks of the intervention; 2 weeks after intervention

Secondary Outcomes (1)

• UHDRS, UPDRS, cognitive measures, mood symptoms, aggression measures, functional ability.

  2 weeks pre intervention; 4 weeks of the intervention; 2 weeks after intervention

Study Arms (2)

Ramelteon

ACTIVE COMPARATOR

Subjects randomized to Ramelteon

Drug: Ramelteon

Placebo

PLACEBO COMPARATOR

Subjects randomized to placebo

Drug: Placebo

Interventions

Ramelteon DRUG

After 2 weeks of baseline sleep study, subjects will be randomized to take either Ramelteon or Placebo for 4 weeks.

Ramelteon

Placebo DRUG

After 2 weeks of baseline sleep study, subjects will be randomized to take either Ramelteon or Placebo for 4 weeks.

Placebo

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with HD will be between the ages of 20 and 65 years old;
• Subjects with PD or DLB will be between the ages of 40 and 90;
• Subjects will have subjective complaints of sleeping problems or their caregivers will complain of the subjects not sleeping well
• Subjects with all severity of HD, PD, and DLB symptoms will be accepted as long as they complain of sleep problems
• A diagnosis of HD, PD, or DLB. For HD patients, a positive HD gene status for everyone except the caregivers will have been obtained for clinical reasons and will be known at the time of enrollment into the study. PD patients will have a clinical diagnosis of PD. DLB patients will have a diagnosis of possible or probably DLB based on consensus criteria (outlined in McKeith et al., 2005).
• Subjects will be willing and able to participate in the informed consent process.

You may not qualify if:

• Subjects who are unable to participate in the informed consent process
• Subjects with previously documented primary sleep disorders (unrelated to HD, PD, or DLB), including Obstructive Sleep Apnea Syndrome, Periodic Limb Movement Disorder of Sleep, or Narcolepsy.
• Subjects taking fluvoxamine, rifampin, ketoconazole , and fluconazole within 30 days of baseline
• Subjects with hepatic impairment
• Subjects who perform shift work or have any other circadian rhythm abnormality or disruption
• Subjects who are diagnosed with a Major Depressive Episode, current at the time of enrollment (subject may have a history of a Major Depressive Episode as long as it is in partial or full remission at the time of enrollment)
• Subjects who are diagnosed with a manic or hypomanic episode, current at the time of enrollment (subject may have a history of a manic or hypomanic episode as long as it is in full remission at the time of enrollment)
• Subjects who at the time of enrollment receive hypnotic agents or have been on hypnotic agents during the two weeks prior to enrollment
• Subjects who are pregnant at the time of enrollment or intend to become pregnant during the period of study participation
• Subjects who in the opinion of the research personnel would not be able to participate in the research protocol because of agitation, lack of transportation, or other reasons.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location

Related Publications (3)

• Hurelbrink CB, Lewis SJ, Barker RA. The use of the Actiwatch-Neurologica system to objectively assess the involuntary movements and sleep-wake activity in patients with mild-moderate Huntington's disease. J Neurol. 2005 Jun;252(6):642-7. doi: 10.1007/s00415-005-0709-z. Epub 2005 Mar 7.

  PMID: 15742112 BACKGROUND

• Morton AJ, Wood NI, Hastings MH, Hurelbrink C, Barker RA, Maywood ES. Disintegration of the sleep-wake cycle and circadian timing in Huntington's disease. J Neurosci. 2005 Jan 5;25(1):157-63. doi: 10.1523/JNEUROSCI.3842-04.2005.

  PMID: 15634777 BACKGROUND

• Ancoli-Israel S, Clopton P, Klauber MR, Fell R, Mason W. Use of wrist activity for monitoring sleep/wake in demented nursing-home patients. Sleep. 1997 Jan;20(1):24-7. doi: 10.1093/sleep/20.1.24.

  PMID: 9130330 BACKGROUND

MeSH Terms

Conditions

Huntington Disease; Parkinson Disease; Lewy Body Disease; Sleep Wake Disorders; Chronobiology Disorders; Parkinsonian Disorders; Dementia

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Synucleinopathies; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaloyan S Tanev, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuropsychiatrist

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 22, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 6, 2012

Record last verified: 2012-11

Locations

US (1)