Actively Recruiting
Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults
Led by Yale University · Updated on 2026-02-03
20
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
Neurocrine Biosciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have given written and witnessed consent to participate
- Male or female adults aged 18 to 65 years
- Be in good health based on medical history, physical exam, lab tests, and ECG
- On stable psychiatric medications for at least 4 weeks prior to the trial with no expected changes
- Agree to use contraception if of child-bearing potential, with specific guidelines for men and women
- Female participants must have negative urine pregnancy tests at screening and regularly throughout the study
- Negative urine drug screen for specified drugs at screening and multiple study visits
- Willing to follow study procedures and return for follow-up visits
- Have symptoms causing marked distress or significant impact on work or social life
- Stable psychiatric status as determined by the investigator
- Meet DSM-5 criteria for trichotillomania
- Have a score of 12 or higher on the Massachusetts General Hospital Hairpulling Scale (MGH-HPS)
You will not qualify if you...
- Diagnosed with bipolar disorder, psychotic disorder, substance use disorder, developmental disorder, or intellectual disability (IQ below 70)
- Recent medication changes within 4 weeks that may affect trichotillomania severity
- Currently taking antipsychotic or dopamine-affecting medications
- Recent changes or new behavioral therapy for trichotillomania or OCD within specified time frames
- Taking medications that may interact with valbenazine or cause QT prolongation unless ECG is normal
- Positive pregnancy or drug screening test
- Currently pregnant or breastfeeding
- Significant medical conditions
- Excessive tobacco or nicotine use within 30 days before screening
- History of substance dependence or abuse within 3 months before baseline
- History of neuroleptic malignant syndrome
- Known long QT syndrome or cardiac arrhythmia
- Abnormal ECG with QTcF over 450 msec or other significant cardiac issues
- Recent significant blood loss or blood/plasma donation within specified time frames
- Risk of suicidal or violent behavior
- Allergy or intolerance to VMAT2 inhibitors
- History of poor compliance in research studies
- Previous exposure to valbenazine or participation in valbenazine trials
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yale Child Study Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
A
Angeli Landeros, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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