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Melatonin Receptor Agonist
Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study
N/A
Waitlist Available
Led By Erin Furr Stimming, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 5, week 9
Summary
This trial is testing if taking melatonin can help people with the Huntington's Disease gene sleep better. Melatonin has been studied for its potential to improve sleep in various populations, including those with sleep disorders and neurodegenerative conditions.
Eligible Conditions
- Huntington's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 5, week 9
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 5, week 9
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Secondary study objectives
Improvement in daytime somnolence, as evaluated by the Epworth Sleepiness Scale (ESS)
Improvement in global cognitive functioning, as assessed by the Montreal cognitive assessment (MoCA)
Improvement in quality of life, as evaluated by the Huntington's Disease Quality of Life Questionnaire (HDQoL)
+2 moreSide effects data
From 2014 Phase 2 trial • 40 Patients • NCT0111437342%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MelatoninExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
956 Previous Clinical Trials
346,041 Total Patients Enrolled
Huntington's Disease Society of AmericaUNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled
Erin Furr Stimming, MD5.09 ReviewsPrincipal Investigator - The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
5Patient Review
Dr. Furr-Stimming is one of the most compassionate people I have ever had the pleasure of meeting, let alone receiving care from. They answered all of my questions thoroughly and with the patience of a saint.