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

• Status: Withdrawn
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

We will recruit 24 Huntington's disease, Parkinson's Disease, or Dementia with Lewy Bodies subjects. Assuming a dropout rate of 20%, we expect that 20 of the 24 subjects who initially enroll will complete the study.

Inclusion criteria will be the following:

• 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.

Exclusion criteria will be the following:

• 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.