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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 belowSelect...
My TTM symptoms are severe, scoring 17 or more.
Select...
I am a woman and my pregnancy test was negative.
Select...
My psychiatric medication has been stable for 4 weeks and won't change during the trial.
Select...
I am a woman and my pregnancy test was negative.
Select...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of long QT syndrome or irregular heartbeats.
Select...
I am currently on medication for mental health that affects dopamine.
Select...
My heart's electrical activity is normal, without significant abnormalities.
Select...
I have not used tobacco or nicotine heavily in the last 30 days.
Select...
I have taken valbenazine or been in a valbenazine study before.
Select...
I have a history of neuroleptic malignant syndrome.
Select...
I started or changed my OCD/TTM treatment less than 12 weeks ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of long QT syndrome or irregular heartbeats.My TTM symptoms are severe, scoring 17 or more.I am in good health based on recent medical exams and tests.I am currently on medication for mental health that affects dopamine.You are allergic or have a strong reaction to VMAT2 inhibitors like tetrabenazine.I have passed a drug test, or I am on stable, prescribed doses of certain medications.I am a woman and my pregnancy test was negative.My heart's electrical activity is normal, without significant abnormalities.My symptoms greatly affect my work or social life.I have not used tobacco or nicotine heavily in the last 30 days.My psychiatric medication has been stable for 4 weeks and won't change during the trial.I am not taking any medication that interacts badly with valbenazine, according to its prescription guidelines.I agree to use contraception consistently during and after the study as required.I have taken valbenazine or been in a valbenazine study before.I have a history of neuroleptic malignant syndrome.I have passed a drug test and any medication I take is prescribed and monitored.You have a history of serious mental health issues that may put you at risk for self-harm or violent behavior.I haven't changed my medication dose or stopped any medication in the last 4 weeks.I have not lost more than 250 mL of blood or donated blood in the last 56 days, nor plasma in the last 7 days.You have other mental health conditions or developmental disabilities like bipolar disorder, schizophrenia, substance abuse problems, or intellectual disability.I started or changed my OCD/TTM treatment less than 12 weeks ago.I am a woman and my pregnancy test was negative.I am between 18 and 65 years old.You meet the diagnostic criteria for Trichotillomania, as defined in the DSM-5.You have other serious health conditions that could affect your ability to participate in the study.You have struggled with drug or alcohol addiction within the past 3 months, as defined by the DSM-5 guidelines for Substance Use Disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Valbenazine
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Trichotillomania Patient Testimony for trial: Trial Name: NCT05207085 — Phase 2
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