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Melatonin Receptor Agonist

Melatonin for Huntington's Disease

N/A

Waitlist Available

Led By Erin Furr Stimming, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 5, week 9

Awards & highlights

Study Summary

This trial is studying how well melatonin works in improving sleep quality in people with a genetic mutation that causes Huntington's disease.

Eligible Conditions

Huntington's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 5, week 9

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 5, week 9

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 5, week 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

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

+2 more

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373

42%

Fatigue

39%

Early Morning Wakening

36%

Daytime drowsiness

11%

Weakness

11%

Dizziness

11%

Nausea

11%

Blurred vision

100%

80%

60%

40%

20%

Study treatment Arm

Melatonin

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MelatoninExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin

2014

Completed Phase 4

~1150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

320,962 Total Patients Enrolled

Huntington's Disease Society of AmericaUNKNOWN

1 Previous Clinical Trials

60 Total Patients Enrolled

Erin Furr Stimming, MD5.09 ReviewsPrincipal Investigator - The University of Texas Health Science Center, Houston

The University of Texas Health Science Center, Houston

5Patient Review

Dr. Furr-Stimming is one of the most compassionate people I have ever had the pleasure of meeting, let alone receiving care from. They answered all of my questions thoroughly and with the patience of a saint.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which patient population is this clinical trial available?

"This trial is accepting 20 participants with Huntington's disease, ranging from 18 to 75 years old. To be considered for the study, candidates must have a score of at least 5 on the Pittsburgh Sleep Quality Index (PSQI), not changed any medications in the last month and possess sufficient mental capacity to make an informed decision about participation."

Answered by AI

How many participants is this clinical trial recruiting?

"Indeed, according to clinicaltrials.gov this medical trial is still accepting patients for recruitment. The study was initially published on January 22nd 2021 and was most recently updated on May 23rd 2022. It requires 20 participants from a single location to complete the research project."

Answered by AI

Does this investigation permit the participation of individuals aged over 35?

"This trial has a relatively broad age requirement of 18 to 75 years old. 34 studies are targeting applicants below the legal age and 127 focus on senior citizens above 65."

Answered by AI

Are there any slots available for recruitment in this clinical investigation?

"According to the clinicaltrials.gov, this medical study is currently enrolling patients; it was initially announced on January 22nd 2021 and had its most recent update approved on May 23rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Erin Furr Stimming 2021. "Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04421339.