RecruitingPhase 2NCT05207085

Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Titration Study to Assess the Safety, Tolerability, and Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults


Sponsor

Yale University

Enrollment

20 participants

Start Date

Feb 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial aims to evaluate the efficacy, safety and tolerability of valbenazine, titrated to the subject's optimal dose of 40mg or 80mg, administered once daily, for 12 weeks, for the treatment of trichotillomania (TTM) in a double blind placebo controlled design study. After week 12, subjects will begin a 12-week, open-label portion of the study. During the open-label portion of the study, all subjects will receive the study drug at their optimal dose. The primary endpoint of these studies will be the change from baseline of placebo vs. active scores utilizing the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) at the end of Week 12.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether valbenazine, a medication already approved for certain movement disorders, can help adults with trichotillomania — a condition where people feel a strong urge to pull out their own hair, causing distress and difficulty in daily life. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with trichotillomania (hair-pulling disorder) based on DSM-5 criteria - Your hair-pulling symptoms cause significant distress or interfere with daily life - You have been on a stable psychiatric medication regimen for at least 4 weeks - You are in good general health **You may NOT be eligible if...** - You have bipolar disorder, a psychotic disorder, substance use disorder, or intellectual disability - You are currently taking antipsychotic medications - You have recently started or changed a behavior therapy for hair-pulling or OCD (within 12 weeks) - You are pregnant, breastfeeding, or have a positive pregnancy test - You have a history of heart rhythm problems (long QT syndrome or arrhythmia) - You have a known allergy to VMAT2 inhibitors (like tetrabenazine) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGValbenazine Oral Capsule

Participants randomized to active treatment will be given a starting dose of 40mg of valbenazine , which may be escalated to 80mg to achieve an optimal dose of the medication for each subject.

OTHERPlacebo Oral capsule

Participants randomized to placebo will be given a capsule that is the same shape and color as the active medication and will subject to the same dose escalation requirements as the other arm but will receive placebo during the treatment period.


Locations(1)

Yale Child Study Center

New Haven, Connecticut, United States

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NCT05207085