WithdrawnPhase NA

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

Treating Sleep Wake Cycle Disturbances in Basal Ganglia Neurodegenerative Disorder Subjects With Ramelteon- A Double Blind, Placebo Controlled Trial

Lead sponsor

Massachusetts General Hospital

Asset

Ramelteon

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criterion

•Dementia with Lewy bodies

Primary endpoint

•Sleep efficiency and other actigraphy derived sleep parameters

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID06-043R

NCT IDNCT00907595

Timeline

Milestones

Study start2009-05 (month precision)

Study first posted2009-05-22estimated

Primary completion2010-03actual (month precision)

Study completion2010-07actual (month precision)

Last update posted2012-11-06estimated

Assets

Drug assets

Ramelteon

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age20 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Sleep efficiency and other actigraphy derived sleep parameters

Time frame:2 weeks pre intervention; 4 weeks of the intervention; 2 weeks after intervention

descriptive

Secondary/protocol endpoint

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

Time frame:2 weeks pre intervention; 4 weeks of the intervention; 2 weeks after intervention

descriptive

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.