Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults

NCT05207085 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 20000349932000026788
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trichotillomania (Hair-Pulling Disorder)

Keywords

trichotillomania; hair-pulling disorder; valbenazine

Outcome Measures

Primary Outcomes (1)

• Change in Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to Week 12

  Massachusetts General Hospital Hairpulling Scale (MGH-HPS) scores range from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 12 weeks.

  baseline to week12

Secondary Outcomes (1)

• Clinical Global Improvement Scale - Trichotillomania Severity (CGI-TTM) score at endpoint

  Week 12

Study Arms (2)

Valbenazine

EXPERIMENTAL

Participants randomized1:1 to receive valbenazine

Drug: Valbenazine Oral Capsule

Placebo

PLACEBO COMPARATOR

Participants randomized 1:1 to receive placebo

Other: Placebo Oral capsule

Interventions

Valbenazine Oral Capsule DRUG

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.

Also known as: Ingrezza

Valbenazine

Placebo Oral capsule OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have documentation of written and witnessed consent from the subject.
• Male or female adult between the ages of 18-65, inclusive.
• Be in good health as determined by medical history, physical examination, laboratory assessments and 12-lead ECG.
• On stable psychiatric medication regime of 4 weeks prior to beginning the trial and not anticipating changes during the trial.
• Subjects of child-bearing potential must agree to use contraception (condoms for men, birth control pill or diaphragm for women) consistently from screening until 30 days (female) or 90 days (male) after the last dose of the study drug. A female subject of childbearing potential is defined as a female capable of becoming pregnant, which includes subjects who have had their first menstrual cycle (i.e., menarche) and are not surgically sterile (i.e., bilateral oophorectomy, hysterectomy or bilateral tubal ligation for at least 3 months prior to screening) or have not experienced menopause and subsequently are no longer of childbearing potential. A male subject of childbearing potential is defined as a subject who has reached spermarche and has not been vasectomized for at least 3 months prior to screening. Subjects who practice total abstinence from sexual intercourse as the preferred lifestyle are not required to use contraception (periodic abstinence is not acceptable).
• Female subjects must have a negative urine pregnancy test at screening, baseline and weeks 2, 4, 8, 12, 14, 16, 20, 24 and 26.
• Negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates) at screening, baseline and weeks 2, 4, 8, 12, 14, 16, 20, 24 and 26. Subjects on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates or psychostimulants (participants with ADHD) can participate in the study. Results from a positive drug screen will be discarded.
• Be willing to adhere to the study regime and study procedures described in the protocol and informed consent forms, including all requirements at the study center and return for the follow-up visit.
• Have symptoms that cause marked distress or significant impairment in occupational and/or social function.
• Have a stable psychiatric status (TTM) as clinically determined by the investigator.
• Meet DSM-5 criteria for TTM.
• Significant current TTM symptoms: 12 or greater score on MGH-HPS.

You may not qualify if:

• Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ\<70).
• Recent changes in medications (less than 4 weeks) in other medications that have potential effects on TTM severity. Medication change is defined to include dose changes or medication discontinuation.
• Currently taking antipsychotic medications or other medications that affect the dopamine system (e.g. psychostimulant medications).
• Recent changes in behavior treatment (less than 4 weeks) or initiation of therapy (within 12 weeks) for TTM/Obsessive Compulsive Disorder (OCD).
• Taking co-medications (over the counter or prescription) that may have a drug interaction with valbenazine as described in the United States Prescribing Information for INGREZZA. Patients who are taking co-medications with the potential to cause QT prolongations will not be excluded unless their ECG shows QT prolongation already present.
• Positive pregnancy test or drug screening test.
• Currently pregnant or lactating.
• Significant medical comorbidity.
• Excessive use of tobacco and/or nicotine-containing products (based on the investigator's assessment or more than 1½ pack of cigarettes per day, 1 can of chewing/dipping tobacco per day, 54mg of nicotine-containing smoking cessation products per day, or any nicotine products or combination of products that exceed 54mg per day) within 30 days of screening.
• History of substance (drug or alcohol) dependence or abuse within 3 months before Baseline, as defined by DSM-5 criteria for Substance Use Disorder.
• Known history of neuroleptic malignant syndrome.
• Known history of long QT syndrome or cardiac arrhythmia.
• Have a screening or Day 1 average triplicate ECG corrected QT interval using Fridericia's formula (QTcF) of \>450msec or the presence of any clinically significant cardiac abnormality.
• Have a blood loss ≥250 mL or donated blood within 56 days or donated plasma within 7 days of Day 1 (baseline).
• Have a significant risk of suicidal or violent behavior based on prior medical history and clinical judgement.

Sponsors & Collaborators

• Yale University: lead
• Neurocrine Biosciences: collaborator

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

RECRUITING

Related Publications (6)

• United States Prescribing Information for INGREZZA. San Diego, CA 92130: Neurocrine Biosciences, Inc.; 2020.

  BACKGROUND

• Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.

  PMID: 27581696 BACKGROUND

• Bloch MH, Landeros-Weisenberger A, Dombrowski P, Kelmendi B, Wegner R, Nudel J, Pittenger C, Leckman JF, Coric V. Systematic review: pharmacological and behavioral treatment for trichotillomania. Biol Psychiatry. 2007 Oct 15;62(8):839-46. doi: 10.1016/j.biopsych.2007.05.019. Epub 2007 Aug 28.

  PMID: 17727824 BACKGROUND

• McGuire JF, Ung D, Selles RR, Rahman O, Lewin AB, Murphy TK, Storch EA. Treating trichotillomania: a meta-analysis of treatment effects and moderators for behavior therapy and serotonin reuptake inhibitors. J Psychiatr Res. 2014 Nov;58:76-83. doi: 10.1016/j.jpsychires.2014.07.015. Epub 2014 Jul 26.

  PMID: 25108618 BACKGROUND

• Franklin ME, Zagrabbe K, Benavides KL. Trichotillomania and its treatment: a review and recommendations. Expert Rev Neurother. 2011 Aug;11(8):1165-74. doi: 10.1586/ern.11.93.

  PMID: 21797657 BACKGROUND

• Sarva H, Henchcliffe C. Valbenazine as the first and only approved treatment for adults with tardive dyskinesia. Expert Rev Clin Pharmacol. 2018 Mar;11(3):209-217. doi: 10.1080/17512433.2018.1429264. Epub 2018 Jan 23.

  PMID: 29338466 BACKGROUND

MeSH Terms

Conditions

Trichotillomania

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Study Officials

• Michael H. Bloch, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angeli Landeros, MD

CONTACT

203737-4539; blochresearch@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 26, 2022
• Study Start: February 2, 2024
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)