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Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Valbenazine for Trichotillomania

Phase 2
Recruiting
Led By Michael H. Bloch, MD
Research Sponsored by Michael Bloch
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Significant current TTM symptoms: 17 or greater score on NIMH-TSS/TIS
Female subjects must have a negative urine pregnancy test at Day 1 (baseline).
Must not have
Known history of long QT syndrome or cardiac arrhythmia
Currently taking antipsychotic medications or other medications that affect the dopamine system (e.g. psychostimulant medications)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12

Summary

This trial tests the effectiveness and safety of valbenazine, a daily medication, for treating people with trichotillomania, a hair-pulling disorder. Participants will receive the medication for a certain period, followed by another period where everyone gets the medication. Valbenazine helps by balancing brain chemicals to reduce hair-pulling urges.

Who is the study for?
Adults aged 18-65 with trichotillomania (TTM) causing significant distress or impairment, who meet DSM-5 criteria for TTM and are on a stable psychiatric medication regime. Participants must be in good health, not pregnant or lactating, agree to use contraception if of child-bearing potential, have no recent drug abuse history, and no known allergies to VMAT2 inhibitors.
What is being tested?
The trial is testing the effectiveness of Valbenazine capsules at doses of 40mg or 80mg daily for treating TTM over a period of 12 weeks. It's a double-blind study where half the participants will receive Valbenazine and the other half a placebo. Afterward, there's an open-label phase where all subjects get Valbenazine.
What are the potential side effects?
While specific side effects for this trial aren't listed, common ones associated with similar medications include sleepiness, balance problems (risk of falls), nausea, headache, dry mouth and blurred vision. Serious side effects might involve heart rhythm changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My TTM symptoms are severe, scoring 17 or more.
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I am a woman and my pregnancy test was negative.
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My psychiatric medication has been stable for 4 weeks and won't change during the trial.
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I am a woman and my pregnancy test was negative.
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of long QT syndrome or irregular heartbeats.
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I am currently on medication for mental health that affects dopamine.
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My heart's electrical activity is normal, without significant abnormalities.
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I have not used tobacco or nicotine heavily in the last 30 days.
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I have taken valbenazine or been in a valbenazine study before.
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I have a history of neuroleptic malignant syndrome.
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I started or changed my OCD/TTM treatment less than 12 weeks ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to Week 12
Secondary study objectives
Clinical Global Improvement Scale - Trichotillomania Severity (CGI-TTM) score at endpoint

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ValbenazineExperimental Treatment1 Intervention
Participants randomized1:1 to receive valbenazine
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized 1:1 to receive placebo

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Trichotillomania include behavioral therapy and pharmacological interventions. Valbenazine, a VMAT2 inhibitor, works by regulating the release of neurotransmitters like dopamine, which can help control compulsive behaviors associated with hair-pulling. This is significant for Trichotillomania patients as it offers a targeted approach to reduce the urge to pull hair by modulating brain chemistry. Other pharmacological treatments may include SSRIs and antipsychotics, which also aim to balance neurotransmitter levels, thereby reducing compulsive behaviors. Understanding these mechanisms helps patients and clinicians make informed decisions about treatment options.

Find a Location

Who is running the clinical trial?

Michael BlochLead Sponsor
Neurocrine BiosciencesIndustry Sponsor
75 Previous Clinical Trials
6,309 Total Patients Enrolled
Yale UniversityLead Sponsor
1,927 Previous Clinical Trials
3,031,712 Total Patients Enrolled
1 Trials studying Trichotillomania
39 Patients Enrolled for Trichotillomania

Media Library

Valbenazine (Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05207085 — Phase 2
Trichotillomania Research Study Groups: Valbenazine, Placebo
Trichotillomania Clinical Trial 2023: Valbenazine Highlights & Side Effects. Trial Name: NCT05207085 — Phase 2
Valbenazine (Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05207085 — Phase 2
Trichotillomania Patient Testimony for trial: Trial Name: NCT05207085 — Phase 2
~8 spots leftby Oct 2025