Huntington DiseaseNCT04421339
Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study
A study testing Melatonin in people with Huntington Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the efficacy of exogenous melatonin in improving sleep quality in HD gene carriers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 16 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of the study is to evaluate the efficacy of exogenous melatonin in improving sleep quality in HD gene carriers.
- Conditions
- Huntington Disease
- Being tested
- Melatonin, Placebo
- Keywords
- Huntington's Disease, Melatonin
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary 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.
PlaceboOther
Participants will receive placebo once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Not described Receives: Dietary Supplement: Melatonin |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 5, week 9
Secondary outcomes (5)
Improvement in sleep quality, as assessed by the Huntington's disease (HD) sleep questionnaire
This questionnaire contained 45 questions that focused on different sleep-related issues such as duration, quality of sleep, abnormal nocturnal behavior and quality of life.
The questionnaire has a total score of 19 points, scores of (0 - 3) represent the 'normal' range whilst, scores of (4 - 6) reflect 'mild' and scores of 7 and above indicate a 'significant' sleep disturbance.
Measured: Baseline, week 5, week 9
Improvement in daytime somnolence, as evaluated by the Epworth Sleepiness Scale (ESS)
The ESS is a questionnaire designed to measure the subject's general level of daytime sleepiness.
This scale scores from 0-24, with higher scores showing severe excessive daytime sleepiness.
Measured: 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
It is an 8-question instrument designed and validated to evaluate perceived difficulties in cognitive abilities (e.g., memory, attention, and decision making, or in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering and learning).
The score ranges from 0-100, with higher scores meaning a better or worse outcome according to the domain evaluated.
Measured: Baseline, week 5, week 9
Improvement in global cognitive functioning, as assessed by the Montreal cognitive assessment (MoCA)
The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction.
Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.
Measured: Baseline, week 5, week 9
Improvement in quality of life, as evaluated by the Huntington's Disease Quality of Life Questionnaire (HDQoL)
It is a disease-specific scale containing 40 questions, with answers including different types of frequency from "never" to "all of the time".
Measured: Baseline, week 5, week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start22 Jan 2021
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Huntington's Disease Society of America
- Responsible party
- Principal investigator, Erin Furr Stimming, The University of Texas Health Science Center, Houston
- Investigators
- Erin Furr Stimming, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421339
- Sponsor's protocol ID
- HSC-MS-19-1111
- Status last verified
- May 2023
- First submitted
- 4 Jun 2020
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40056659
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study
- ClinicalTrials.gov ID
- NCT04421339
- Acronym / sponsor ID
- HSC-MS-19-1111
- Conditions
- Huntington Disease
- Keywords
- Huntington's Disease, Melatonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Huntington's Disease Society of America
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy of exogenous melatonin in improving sleep quality in HD gene carriers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Dietary Supplement: Melatonin |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninParticipants will receive melatonin 5 mg once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over. | Dietary supplement | Melatonin |
| PlaceboParticipants will receive placebo once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over. | Other | Placebo |
Primary outcome
Change in sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, week 5, week 9
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.
5 secondary outcomes
Improvement in sleep quality, as assessed by the Huntington's disease (HD) sleep questionnaire
Time frame: Baseline, week 5, week 9
Improvement in daytime somnolence, as evaluated by the Epworth Sleepiness Scale (ESS)
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Derived from this study: PubMed 40056659Zadegan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Furr Stimming, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Huntington Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline, week 5, week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04421339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.