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Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study

NCT04421339 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-05-15

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy of exogenous melatonin in improving sleep quality in HD gene carriers.

Conditions

  • Huntington Disease

Interventions

DIETARY_SUPPLEMENT

Melatonin

Participants will receive melatonin 5 mg once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.

OTHER

Placebo

Participants will receive placebo once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.

Sponsors & Collaborators

  • Huntington's Disease Society of America

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Erin Furr Stimming, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-22
Primary Completion
2022-09-16
Completion
2022-09-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04421339 on ClinicalTrials.gov