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

NCT04421339 | Completed DMC

• 1 other identifier: HSC-MS-19-1111
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Huntington's Disease; Melatonin

Outcome Measures

Primary Outcomes (1)

• Change in sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI)

  The PSQI is a 9-question instrument used to measure the quality and patterns of sleep in adults. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper.

  Baseline, week 5, week 9

Secondary Outcomes (5)

• Improvement in sleep quality, as assessed by the Huntington's disease (HD) sleep questionnaire

  Baseline, week 5, week 9

• Improvement in daytime somnolence, as evaluated by the Epworth Sleepiness Scale (ESS)

  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

  Baseline, week 5, week 9

• Improvement in global cognitive functioning, as assessed by the Montreal cognitive assessment (MoCA)

  Baseline, week 5, week 9

• Improvement in quality of life, as evaluated by the Huntington's Disease Quality of Life Questionnaire (HDQoL)

  Baseline, week 5, week 9

Study Arms (2)

Melatonin

EXPERIMENTAL

Dietary Supplement: Melatonin

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Melatonin 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.

Melatonin

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Verified HD mutation carriers.
• Patients who report sleep disturbance as measured by a score ≥5 on the Pittsburgh Sleep Quality Index (PSQI);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Huntington's Disease Society of America: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Zadegan SA, Karagas N, Tanigaki W, Duncan B, Dongarwar D, Patino J, Rocha NP, Furr Stimming E. Melatonin for Huntington's Disease (HD) gene carriers with HD-related sleep disturbance - A pilot study. Sleep Med. 2025 May;129:238-244. doi: 10.1016/j.sleep.2025.02.032. Epub 2025 Mar 4.

  PMID: 40056659 DERIVED

MeSH Terms

Conditions

Huntington Disease

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Erin Furr Stimming, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: January 22, 2021
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)