Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-22

Study Completion Date

2022-09-16

Brief Summary

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

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Detailed Description

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Conditions

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Huntington Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Melatonin

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Verified HD mutation carriers.
* Patients who report sleep disturbance as measured by a score ≥5 on the Pittsburgh Sleep Quality Index (PSQI);
* Stable concomitant medication (no change of medication during last 30 days prior to inclusion);
* Written informed consent by prospective study participant before conduct of any trial-related procedure;
* Participant must be able to make an informed decision of whether or not to participate in the study.

Exclusion Criteria

* Pregnant or nursing women;
* Woman of childbearing potential, not using highly effective methods of contraception such as oral, topical or injected contraception, intrauterine device (IUD), contraceptive vaginal ring, or double barrier method such as diaphragm and condom with spermicide) or not surgically sterile (via hysterectomy, ovariectomy or bilateral tubal ligation) or not at least one year post menopausal;
* Presence of any medically not controllable disease (e.g. uncontrolled arterial hypertension or diabetes mellitus);
* Use of benzodiazepines, sedating antidepressants (mirtazapine or trazodone) or sedating antipsychotics (olanzapine and quetiapine) in the previous four weeks;
* Severe cognitive disorders defined as a score \< 18 on the MOCA;
* Participation in another investigative drug trial within 2 months;
* Subjects who are unlikely to be compliant and attend scheduled clinic visits as required as determined by the Investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No