<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04421339</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-19-1111</org_study_id>
    <nct_id>NCT04421339</nct_id>
  </id_info>
  <brief_title>Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study</brief_title>
  <official_title>Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Huntington's Disease Society of America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the efficacy of exogenous melatonin in improving&#xD;
      sleep quality in HD gene carriers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2021</start_date>
  <completion_date type="Actual">September 16, 2022</completion_date>
  <primary_completion_date type="Actual">September 16, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>Baseline, week 5, week 9</time_frame>
    <description>The PSQI is a 9-question instrument used to measure the quality and patterns of sleep in adults.&#xD;
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 &quot;5&quot;or greater indicates a &quot;poor&quot; sleeper.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in sleep quality, as assessed by the Huntington's disease (HD) sleep questionnaire</measure>
    <time_frame>Baseline, week 5, week 9</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in daytime somnolence, as evaluated by the Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>Baseline, week 5, week 9</time_frame>
    <description>The ESS is a questionnaire designed to measure the subject's general level of daytime sleepiness.&#xD;
This scale scores from 0-24, with higher scores showing severe excessive daytime sleepiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in self-perceived cognitive function, as assessed by the Quality of Life in Neurological Disorders questionnaire (NeuroQOLv2.0) Cognition Function - Short Form</measure>
    <time_frame>Baseline, week 5, week 9</time_frame>
    <description>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).&#xD;
The score ranges from 0-100, with higher scores meaning a better or worse outcome according to the domain evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in global cognitive functioning, as assessed by the Montreal cognitive assessment (MoCA)</measure>
    <time_frame>Baseline, week 5, week 9</time_frame>
    <description>The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction.&#xD;
Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in quality of life, as evaluated by the Huntington's Disease Quality of Life Questionnaire (HDQoL)</measure>
    <time_frame>Baseline, week 5, week 9</time_frame>
    <description>It is a disease-specific scale containing 40 questions, with answers including different types of frequency from &quot;never&quot; to &quot;all of the time&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Huntington Disease</condition>
  <arm_group>
    <arm_group_label>Melatonin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Melatonin</intervention_name>
    <description>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.</description>
    <arm_group_label>Melatonin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive placebo once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Verified HD mutation carriers.&#xD;
&#xD;
          -  Patients who report sleep disturbance as measured by a score ≥5 on the Pittsburgh&#xD;
             Sleep Quality Index (PSQI);&#xD;
&#xD;
          -  Stable concomitant medication (no change of medication during last 30 days prior to&#xD;
             inclusion);&#xD;
&#xD;
          -  Written informed consent by prospective study participant before conduct of any&#xD;
             trial-related procedure;&#xD;
&#xD;
          -  Participant must be able to make an informed decision of whether or not to participate&#xD;
             in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing women;&#xD;
&#xD;
          -  Woman of childbearing potential, not using highly effective methods of contraception&#xD;
             such as oral, topical or injected contraception, intrauterine device (IUD),&#xD;
             contraceptive vaginal ring, or double barrier method such as diaphragm and condom with&#xD;
             spermicide) or not surgically sterile (via hysterectomy, ovariectomy or bilateral&#xD;
             tubal ligation) or not at least one year post menopausal;&#xD;
&#xD;
          -  Presence of any medically not controllable disease (e.g. uncontrolled arterial&#xD;
             hypertension or diabetes mellitus);&#xD;
&#xD;
          -  Use of benzodiazepines, sedating antidepressants (mirtazapine or trazodone) or&#xD;
             sedating antipsychotics (olanzapine and quetiapine) in the previous four weeks;&#xD;
&#xD;
          -  Severe cognitive disorders defined as a score &lt; 18 on the MOCA;&#xD;
&#xD;
          -  Participation in another investigative drug trial within 2 months;&#xD;
&#xD;
          -  Subjects who are unlikely to be compliant and attend scheduled clinic visits as&#xD;
             required as determined by the Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erin Furr Stimming, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Erin Furr Stimming</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Huntington's Disease</keyword>
  <keyword>Melatonin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Huntington Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421339
org study id: HSC-MS-19-1111
nct id: NCT04421339
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate the efficacy of exogenous melatonin in improving
      sleep quality in HD gene carriers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Change in sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI)
time frame: Baseline, week 5, week 9
description: 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.
measure: Improvement in sleep quality, as assessed by the Huntington's disease (HD) sleep questionnaire
time frame: Baseline, week 5, week 9
description: 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.
measure: Improvement in daytime somnolence, as evaluated by the Epworth Sleepiness Scale (ESS)
time frame: Baseline, week 5, week 9
description: 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.
measure: 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
description: 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.
measure: Improvement in global cognitive functioning, as assessed by the Montreal cognitive assessment (MoCA)
time frame: Baseline, week 5, week 9
description: 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.
measure: Improvement in quality of life, as evaluated by the Huntington's Disease Quality of Life Questionnaire (HDQoL)
time frame: Baseline, week 5, week 9
description: It is a disease-specific scale containing 40 questions, with answers including different types of frequency from "never" to "all of the time".
arm group label: Melatonin
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Melatonin
description: 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.
arm group label: Melatonin
intervention type: Other
intervention name: Placebo
description: Participants will receive placebo once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Erin Furr Stimming, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Erin Furr Stimming
investigator title: Associate Professor
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Huntington Disease
mesh term: Melatonin
sharing ipd: No