Treating Sleep Wake Cycle Disturbances in Huntington's Disease Subjects With Ramelteon
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, May 2009
First Received: May 20, 2009 Last Updated: May 21, 2009
History of Changes
Sponsored by:
Massachusetts General Hospital
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00907595
Purpose
The investigators are conducting a study of the medication Ramelteon in persons between the ages of 20 and 65 who have tested positive for Huntington Disease (HD) and are complaining of trouble sleeping. This study is designed to determine the effects of 4 weeks Ramelteon treatment on the sleep patterns of people with HD. The study also aims to look at the sleep patterns of caregivers of people with HD.
Condition
Intervention
Huntington's DiseaseSleep DisordersCircadian Dysregulation
Drug: RamelteonDrug: Placebo
Genetics Home Reference related topics: chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome
MedlinePlus related topics: Huntington's Disease Hurricanes Sleep Disorders
Drug Information available for: Ramelteon
U.S. FDA Resources
Study Type:
Interventional
Study Design:
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:
Treating Sleep Wake Cycle Disturbances in Huntington's Disease Subjects With Ramelteon - a Double Blind, Placebo Controlled Trial
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
Sleep efficiency and other actigraphy derived sleep parameters [ Time Frame: 2 weeks pre intervention; 4 weeks of the intervention; 2 weeks after intervention ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
HD-related neurological measures, cognitive measures, mood symptoms, aggression measures, functional ability. [ Time Frame: 2 weeks pre intervention; 4 weeks of the intervention; 2 weeks after intervention ] [ Designated as safety issue: Yes ]
Estimated Enrollment:
24
Study Start Date:
May 2009
Estimated Study Completion Date:
May 2011
Estimated Primary Completion Date:
May 2011 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Ramelteon: Active Comparator
Subjects randomized to Ramelteon
Drug: Ramelteon
After 2 weeks of baseline sleep study, subjects will be randomized to take either Ramelteon or Placebo for 4 weeks.
Placebo: Placebo Comparator
Subjects randomized to placebo
Drug: Placebo
After 2 weeks of baseline sleep study, subjects will be randomized to take either Ramelteon or Placebo for 4 weeks. Detailed Description:
Previous studies on sleep patterns in Huntington's Disease (HD) subjects suggest that there are sleep/wake cycle abnormalities in HD subjects, that these abnormalities are probably related to the severity of HD symptoms, and that they lead to distress for HD patients and their caregivers alike. The proposed study is a double-blind, placebo controlled pilot study of HD subjects with sleep disturbances. It aims to assess the effects of Ramelteon, a drug that functions as a melatonin receptor agonist, on sleep patterns in HD subjects. Additionally, the study attempts to determine whether sleep wake disturbances in HD subjects are associated with sleep wake disturbances in their caregivers. The study will use actigraphy as an objective measure of sleep wake cycles.
Eligibility
Ages Eligible for Study:
20 Years to 65 Years
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
Subjects will be between the ages of 20 and 65 years old.
Subjects will have subjective complaints of problem sleeping or their caregivers will complain of the subjects not sleeping well
Subjects with all severity of HD symptoms will be accepted as long as they complain of sleep problems
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
Exclusion Criteria:
Subjects below the age of 20 or above 65 years old
Subjects who are unable to participate in the informed consent process
Subjects with previously documented primary sleep disorders (unrelated to HD), including Obstructive Sleep Apnea Syndrome, Periodic Limb Movement Disorder of Sleep, or Narcolepsy
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907595
Contacts
Contact: Kaloyan S Tanev, MD
617-726-7511
mailto:ktanev%40partners.org?subject=NCT00907595,
Contact: Angela Hu
617-726-5486
mailto:ahu1%40partners.org?subject=NCT00907595,
Locations
United States, Massachusetts
Massachusetts General Hospital
Recruiting
Boston, Massachusetts, United States, 02144
Contact: Kaloyan S Tanev, MD 617-726-7511 mailto:ktanev%40partners.org?subject=NCT00907595,
Contact: Angela Hu 617-726-5486 mailto:ahu1%40partners.org?subject=NCT00907595,
Principal Investigator: Kaloyan S Tanev, MD
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator:
Kaloyan S Tanev, MD
Massachusetts General Hospital
More Information
Publications:
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. Epub 2005 Mar 7.
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. Erratum in: J Neurosci. 2005 Apr 13;25(15):3994.
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.
Responsible Party:
Massachusetts General Hospital ( Kaloyan Tanev )
Study ID Numbers:
06-043R
Study First Received:
May 20, 2009
Last Updated:
May 21, 2009
ClinicalTrials.gov Identifier:
NCT00907595
Sponsored by:
Massachusetts General Hospital
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00907595
Purpose
The investigators are conducting a study of the medication Ramelteon in persons between the ages of 20 and 65 who have tested positive for Huntington Disease (HD) and are complaining of trouble sleeping. This study is designed to determine the effects of 4 weeks Ramelteon treatment on the sleep patterns of people with HD. The study also aims to look at the sleep patterns of caregivers of people with HD.
Condition
Intervention
Huntington's DiseaseSleep DisordersCircadian Dysregulation
Drug: RamelteonDrug: Placebo
Genetics Home Reference related topics: chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome
MedlinePlus related topics: Huntington's Disease Hurricanes Sleep Disorders
Drug Information available for: Ramelteon
U.S. FDA Resources
Study Type:
Interventional
Study Design:
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:
Treating Sleep Wake Cycle Disturbances in Huntington's Disease Subjects With Ramelteon - a Double Blind, Placebo Controlled Trial
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
Sleep efficiency and other actigraphy derived sleep parameters [ Time Frame: 2 weeks pre intervention; 4 weeks of the intervention; 2 weeks after intervention ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
HD-related neurological measures, cognitive measures, mood symptoms, aggression measures, functional ability. [ Time Frame: 2 weeks pre intervention; 4 weeks of the intervention; 2 weeks after intervention ] [ Designated as safety issue: Yes ]
Estimated Enrollment:
24
Study Start Date:
May 2009
Estimated Study Completion Date:
May 2011
Estimated Primary Completion Date:
May 2011 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Ramelteon: Active Comparator
Subjects randomized to Ramelteon
Drug: Ramelteon
After 2 weeks of baseline sleep study, subjects will be randomized to take either Ramelteon or Placebo for 4 weeks.
Placebo: Placebo Comparator
Subjects randomized to placebo
Drug: Placebo
After 2 weeks of baseline sleep study, subjects will be randomized to take either Ramelteon or Placebo for 4 weeks. Detailed Description:
Previous studies on sleep patterns in Huntington's Disease (HD) subjects suggest that there are sleep/wake cycle abnormalities in HD subjects, that these abnormalities are probably related to the severity of HD symptoms, and that they lead to distress for HD patients and their caregivers alike. The proposed study is a double-blind, placebo controlled pilot study of HD subjects with sleep disturbances. It aims to assess the effects of Ramelteon, a drug that functions as a melatonin receptor agonist, on sleep patterns in HD subjects. Additionally, the study attempts to determine whether sleep wake disturbances in HD subjects are associated with sleep wake disturbances in their caregivers. The study will use actigraphy as an objective measure of sleep wake cycles.
Eligibility
Ages Eligible for Study:
20 Years to 65 Years
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
Subjects will be between the ages of 20 and 65 years old.
Subjects will have subjective complaints of problem sleeping or their caregivers will complain of the subjects not sleeping well
Subjects with all severity of HD symptoms will be accepted as long as they complain of sleep problems
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
Exclusion Criteria:
Subjects below the age of 20 or above 65 years old
Subjects who are unable to participate in the informed consent process
Subjects with previously documented primary sleep disorders (unrelated to HD), including Obstructive Sleep Apnea Syndrome, Periodic Limb Movement Disorder of Sleep, or Narcolepsy
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907595
Contacts
Contact: Kaloyan S Tanev, MD
617-726-7511
mailto:ktanev%40partners.org?subject=NCT00907595,
Contact: Angela Hu
617-726-5486
mailto:ahu1%40partners.org?subject=NCT00907595,
Locations
United States, Massachusetts
Massachusetts General Hospital
Recruiting
Boston, Massachusetts, United States, 02144
Contact: Kaloyan S Tanev, MD 617-726-7511 mailto:ktanev%40partners.org?subject=NCT00907595,
Contact: Angela Hu 617-726-5486 mailto:ahu1%40partners.org?subject=NCT00907595,
Principal Investigator: Kaloyan S Tanev, MD
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator:
Kaloyan S Tanev, MD
Massachusetts General Hospital
More Information
Publications:
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. Epub 2005 Mar 7.
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. Erratum in: J Neurosci. 2005 Apr 13;25(15):3994.
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.
Responsible Party:
Massachusetts General Hospital ( Kaloyan Tanev )
Study ID Numbers:
06-043R
Study First Received:
May 20, 2009
Last Updated:
May 21, 2009
ClinicalTrials.gov Identifier:
NCT00907595
Keywords provided by Massachusetts General Hospital:
