Valbenazine for Trichotillomania

Overseen By Angeli Landeros, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Michael Bloch

Must not be taking: Antipsychotics, Psychostimulants

Disqualifiers: Bipolar, Psychotic, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of valbenazine, a medication for treating trichotillomania, a condition characterized by the urge to pull out hair. Researchers aim to determine if this medication can alleviate the distress and social issues associated with the condition by comparing it to a placebo, which contains no active drug. Participants will take the medication for 12 weeks, followed by an open-label phase where all receive the medication. Eligible participants should have noticeable trichotillomania symptoms and have not recently changed their psychiatric medications or therapy. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable psychiatric medication regime for at least 4 weeks before starting and do not anticipate changes during the trial. If you are taking medications that might interact with valbenazine, you may need to stop those, but the protocol does not specify all medications that must be stopped.

Is there any evidence suggesting that valbenazine is likely to be safe for humans?

Research shows that the FDA has already approved valbenazine for treating tardive dyskinesia, a movement disorder, indicating its safety for people with that condition. Studies have shown that it generally has a safe side-effect profile, meaning it usually doesn't cause serious side effects. Reports from previous trials noted that valbenazine was well-tolerated, meaning most people didn’t experience major problems with it. These findings can reassure those considering joining a trial for trichotillomania about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for trichotillomania?

Researchers are excited about valbenazine for trichotillomania because it offers a different approach compared to current treatments like behavioral therapy and SSRIs. Unlike these standard options, valbenazine works by targeting the brain's dopamine pathways, which are thought to play a role in the urge to pull hair. This new mechanism of action could potentially provide relief for those who haven't found success with existing treatments.

What evidence suggests that valbenazine might be an effective treatment for trichotillomania?

Research has shown that valbenazine, a medication that reduces dopamine, might help treat trichotillomania, a condition characterized by a strong urge to pull out hair. In this trial, participants will receive either valbenazine or a placebo at random. Valbenazine is already used for other conditions involving involuntary movements, suggesting it could also help control urges in trichotillomania. Studies with similar medications have demonstrated a reduction in these urges and an improvement in symptoms. Although data specifically for trichotillomania is limited, positive results in related conditions suggest valbenazine could be effective. Early research findings are encouraging, indicating it might help reduce hair-pulling behaviors. ^{1 2 3 5 6}

Who Is on the Research Team?

Michael H. Bloch, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My TTM symptoms are severe, scoring 17 or more.

I am in good health based on recent medical exams and tests.

I have passed a drug test, or I am on stable, prescribed doses of certain medications.

Exclusion Criteria

I have a history of long QT syndrome or irregular heartbeats.

I am currently on medication for mental health that affects dopamine.

You are allergic or have a strong reaction to VMAT2 inhibitors like tetrabenazine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive valbenazine or placebo for 12 weeks with dose titration to optimal levels

12 weeks

6 visits (in-person, every 2 weeks)

Open-label Extension

All participants receive open-label valbenazine for 12 weeks at their optimal dose

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Oral capsule
• Valbenazine

Trial Overview 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.

How Is the Trial Designed?

Group I: Valbenazine Experimental Treatment 1 Intervention

Participants randomized1:1 to receive valbenazine

Group II: Placebo Placebo Group 1 Intervention

Participants randomized 1:1 to receive placebo

Valbenazine is already approved in United States for the following indications:

Approved in United States as Ingrezza for:

• Tardive dyskinesia
• Chorea associated with Huntington's disease

Who Is Running the Clinical Trial?

Michael Bloch

Lead Sponsor

Trials

1

Recruited

20+

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Neurocrine Biosciences

Industry Sponsor

Trials

78

Recruited

6,600+

Kyle W. Gano

Neurocrine Biosciences

Chief Executive Officer since 2024

PhD in Pharmacology

Dr. Sanjay Keswani

Neurocrine Biosciences

Chief Medical Officer

MD

Published Research Related to This Trial

A ten-year-old boy with a two-year history of trichotillomania and depression did not respond well to imipramine, which had limited effects on his symptoms.

However, treatment with low-dosage fluoxetine (10 mg daily) resulted in significant improvement in both his trichotillomania and depression, suggesting fluoxetine may be a more effective option for similar cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoxetine treatment of trichotillomania and depression in a prepubertal child. Sheikha, SH., Wagner, KD., Wagner, RF.[2013]

In a case study of a single patient with treatment-resistant trichotillomania (TTM), the atypical neuroleptic Aripiprazole led to a complete cessation of hair-plucking that was maintained for 24 months.

This is the first reported instance of Aripiprazole being effective in treating TTM, suggesting that it may be a promising option for further research in managing this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reversal of trichotillomania with aripiprazole. Jefferys, D., Burrows, G.[2018]

In a pilot study of 14 children with childhood-onset trichotillomania, naltrexone was well tolerated at a mean dose of 66.07 mg/day, with 11 out of 14 patients showing a positive response in reducing hair pulling behaviors over a 10-month period.

No liver function abnormalities or adverse effects were reported, indicating that naltrexone may be a safe option for managing trichotillomania in children, but further research with larger sample sizes is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label pilot study of naltrexone in childhood-onset trichotillomania. De Sousa, A.[2013]

In a small study involving three patients with trichotillomania (TTM) who did not respond to serotonin reuptake inhibitors (SRIs), the addition of low-dose risperidone (0.5 to 3 mg/day) led to a significant reduction in hair pulling behavior.

These findings suggest that risperidone may be an effective treatment option for patients with SRI-refractory TTM, potentially offering a safer side effect profile compared to other neuroleptics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risperidone addition in serotonin reuptake inhibitor-resistant trichotillomania: three cases. Epperson, CN., Fasula, D., Wasylink, S., et al.[2022]

In a small study of three patients with self-inflicted skin conditions, treatment with the atypical antipsychotic olanzapine for 2 to 4 weeks led to favorable responses in their symptoms.

The improvement in two of the patients was likely linked to a reduction in dissociative symptoms, suggesting that olanzapine may help address underlying psychological factors contributing to these self-inflicted dermatoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olanzapine is effective in the management of some self-induced dermatoses: three case reports. Gupta, MA., Gupta, AK.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05207085

Study Details | NCT05207085 | Efficacy of Valbenazine for ... 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 ...

2. clinicaltrial.be clinicaltrial.be/en/details/18448?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Efficacy of Valbenazine for the Treatment of Trichotillom... Eligible subjects will be randomized in a double-blind manner in a 1:1 ratio to once-daily doses of valbenazine or placebo for 12 weeks.

3. yalemedicine.org yalemedicine.org/clinical-trials/nbi-98854-for-the-treatment-of-trichotillomania-in-adults-2

Valbenazine for Trichotillomania in Adults This study will examine the efficacy of Valbenazine for the treatment of trichotillomania. Valbenazine is a dopamine-depleting agent that is ...

4. medicine.yale.edu medicine.yale.edu/childstudy/research/clinical-innovations/bloch-lab/trichotillomania-clinical-trials/

Trichotillomania Clinical Trials < Child Study Center This study will examine the efficacy of Valbenazine for the treatment of trichotillomania. Valbenazine is a dopamine-depleting agent that is currently FDA- ...

5. withpower.com withpower.com/trial/phase-2-trichotillomania-3-2022-ec709

Valbenazine for Trichotillomania · Recruiting Participants ... This trial tests the effectiveness and safety of valbenazine, a daily medication, for treating people with trichotillomania, a hair-pulling disorder.

6. ingrezza.com ingrezza.com/huntingtons-chorea/safety-side-effects

Safety and side effects of INGREZZA for HD chorea Find clinical trial safety information & common side effects of INGREZZA® for the treatment of HD chorea. See PI, including Boxed Warning, and Med Guide.