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Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Tetrabenazine for Huntington's Disease

Phase 4
Recruiting
Led By William G Ondo, MD
Research Sponsored by William Ondo, MD
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 and 8 weeks
Awards & highlights

Study Summary

This trial will test whether tetrabenazine, used to treat Huntington's Disease, can also reduce impulsivity in patients with HD. Researchers will also study how the medicine affects thinking and mood.

Eligible Conditions
  • Huntington's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 8 weeks 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 Score on the Barrat Impulsivity Scale
Change in Score on the Geriatric Depression Scale
Change in Score on the Iowa Gambling Task
+3 more
Secondary outcome measures
Change in Score on the United Huntington's Disease Rating Scale - Motor section

Side effects data

From 2013 Phase 2 trial • 102 Patients • NCT01733121
10%
Fatigue
10%
Headache
8%
Decreased appetite
6%
Dry mouth
6%
Nausea
6%
Vomiting
6%
Somnolence
4%
Constipation
4%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Valbenazine

Trial Design

1Treatment groups
Experimental Treatment
Group I: TetrabenazineExperimental Treatment1 Intervention
Xenazine (tetrabenazine), pill, dosage titrated to effect, three times a day, 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tetrabenazine
FDA approved

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SIndustry Sponsor
325 Previous Clinical Trials
77,563 Total Patients Enrolled
William Ondo, MDLead Sponsor
4 Previous Clinical Trials
61 Total Patients Enrolled
William G Ondo, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
5 Previous Clinical Trials
191 Total Patients Enrolled

Frequently Asked Questions

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

What is the primary purpose of Tetrabenazine medication?

"Tetrabenazine is regularly employed to manage gilles de la tourette's syndrome and can also be used for hemiballismus, tardive dyskinesia (TD), as well as Huntington disease."

Answered by AI

What is the current enrollment for this clinical trial?

"Affirmative. The clinicaltrials.gov website mentions that the trial is still recruiting participants, which started in August 2018 and was updated lastly on September 1st 2022. Obtaining 20 individuals from a single site is the goal of this investigation."

Answered by AI

What is the criteria for enrolling in this clinical experiment?

"This experiment seeks 20 individuals suffering from Huntington's disease aged between 18 and 80. Crucially, they must display moderate impulsivity as judged by the Barrat Impulsivity Scale (BIS) (>65), and be fully cognizant with an ability to comprehend instructions."

Answered by AI

Have there been prior studies utilizing Tetrabenazine as a treatment?

"Currently, there is one open clinical trial for Tetrabenazine with no Phase 3 trials. Though Houston, Texas has the most sites running tests on this medication, there are still a total of 1 other locations conducting research."

Answered by AI

Does the age threshold of forty encompass potential participants in this research?

"Eligibility for this trial is limited to individuals aged 18 or older and below 80 years in age."

Answered by AI

Is this experiment the pioneering initiative of its kind?

"Currently, there exists a single clinical trial for Tetrabenazine that is active in 1 metropolis and nation. This drug's first experiment was conducted two years ago with 20 participants sponsored by H. Lundbeck A/S which achieved the final Phase 4 approval stage of medication testing. Since 2018, seven other trials have been completed as well."

Answered by AI

Has Tetrabenazine been validated by the FDA?

"There is previously collected evidence to affirm the safety of Tetrabenazine, which has been approved for use in Phase 4 trials, so it achieved a rating of 3."

Answered by AI

Are there any unfilled vacancies for this medical trial?

"Affirmative. As per the information on clinicaltrials.gov, this medical trial is presently seeking out participants; it was posted online on August 1st 2018 and most recently updated September 1st 2022. The study requires 20 patients from one location to take part in the research."

Answered by AI
~3 spots leftby Apr 2025