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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04421339
Date of registration: 04/06/2020
Prospective Registration: Yes
Primary sponsor: The University of Texas Health Science Center, Houston
Public title: Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study
Scientific title: Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study
Date of first enrolment: October 7, 2020
Target sample size: 20
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04421339
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Erin Furr Stimming, MD
Address: 
Telephone: 713-500-7033
Email: Erin.E.Furr@uth.tmc.edu
Affiliation: 
Name:     Erin Furr Stimming, MD
Address: 
Telephone: 7135007033
Email: Erin.E.Furr@uth.tmc.edu
Affiliation: 
Name:     Erin Furr Stimming, MD
Address: 
Telephone:
Email:
Affiliation:  The University of Texas Health Science Center, Houston
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Huntington Disease
Intervention(s)
Dietary Supplement: Melatonin
Other: Placebo
Primary Outcome(s)
Change in sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI) [Time Frame: Baseline, week 5, week 9]
Secondary Outcome(s)
Improvement in daytime somnolence, as evaluated by the Epworth Sleepiness Scale (ESS) [Time Frame: Baseline, week 5, week 9]
Improvement in global cognitive functioning, as assessed by the Montreal cognitive assessment (MoCA) [Time Frame: Baseline, week 5, week 9]
Improvement in quality of life, as evaluated by the Huntington's Disease Quality of Life Questionnaire (HDQoL) [Time Frame: Baseline, week 5, week 9]
Improvement in self-perceived cognitive function, as assessed by the Quality of Life in Neurological Disorders questionnaire (NeuroQOLv2.0) Cognition Function - Short Form [Time Frame: Baseline, week 5, week 9]
Improvement in sleep quality, as assessed by the Huntington's disease (HD) sleep questionnaire [Time Frame: Baseline, week 5, week 9]
Secondary ID(s)
HSC-MS-19-1111
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Huntington's Disease Society of America
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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