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

  • STATUS
    Recruiting
  • days left to enroll
    37
  • participants needed
    20
  • sponsor
    The University of Texas Health Science Center, Houston
Updated on 7 June 2022
change of medication
chorea

Summary

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

Details
Condition Huntington Disease
Treatment Placebo, Melatonin
Clinical Study IdentifierNCT04421339
SponsorThe University of Texas Health Science Center, Houston
Last Modified on7 June 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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