Clinical trial NCT04421339: Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study
Official title: Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Huntington Disease
Keywords: Huntington's Disease
Melatonin
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Huntington's Disease Society of America
First posted: 2020-06-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, week 5, week 9
Secondary outcomes:
measure: Improvement in sleep quality, as assessed by the Huntington's disease (HD) sleep questionnaire
timeFrame: Baseline, week 5, week 9
measure: Improvement in daytime somnolence, as evaluated by the Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, week 5, week 9
measure: Improvement in self-perceived cognitive function, as assessed by the Quality of Life in Neurological Disorders questionnaire (NeuroQOLv2.0) Cognition Function - Short Form
timeFrame: Baseline, week 5, week 9
measure: Improvement in global cognitive functioning, as assessed by the Montreal cognitive assessment (MoCA)
timeFrame: Baseline, week 5, week 9
measure: Improvement in quality of life, as evaluated by the Huntington's Disease Quality of Life Questionnaire (HDQoL)
timeFrame: Baseline, week 5, week 9
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Erin Furr Stimming, MD
role: PRINCIPAL_INVESTIGATOR
References: