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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Study Summary
This trial is testing a new medication, valbenazine, to see if it is effective in treating trichotillomania (TTM). The trial will last for 12 weeks and will have a group of people taking valbenazine and a group taking a placebo. The primary endpoint of the trial is the change from baseline of the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) scores at the end of Week 12.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to Week 12
Secondary outcome measures
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
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Who is running the clinical trial?
Michael BlochLead Sponsor
Neurocrine BiosciencesIndustry Sponsor
75 Previous Clinical Trials
6,731 Total Patients Enrolled
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,421 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA recognize Valbenazine Oral Capsule as a legitimate medication?
"Although there is evidence of Valbenazine's safety, no verification of efficacy exists yet. Consequently, its safety rating on our scale stands at 2."
Answered by AI
Who meets the eligibility criteria for this trial?
"Candidates for the trial should have trichotillomania and be between 18-65 years of age. The medical team is working to register a total of 20 participants in this study."
Answered by AI
Is participation in this research project restricted to individuals under 40 years of age?
"The requirements to enroll in this medical study dictate that participants must be aged 18 or higher, with a cut-off of 65 years old."
Answered by AI
Does this experiment currently accept participants?
"Info posted on clinicaltrials.gov demonstrates that this medical trial, initially launched on November 15th 2022 and most recently updated September 23rd 2022, is not currently open for recruitment. However, 6 other research studies are actively enrolling participants at the moment."
Answered by AI
Who else is applying?
What state do they live in?
Iowa
California
Massachusetts
Other
How old are they?
18 - 65
What site did they apply to?
Yale Child Study Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+
What questions have other patients asked about this trial?
What is the timeframe for the trial? When does it start?
PatientReceived no prior treatments
Why did patients apply to this trial?
I have tried everything to stop. Drugs, therapy, etc. I’ve tried NAC, Olanzapine, Inisitol, Lamictal, many therapies and OCD coaches, SSRIs. I’m mostly bald and have worn a wig for a few years.
PatientReceived 2+ prior treatments
I’ve struggled with trichotillomania since I was 10/11. It’s been debilitating and a huge blow to my confidence. Many years I’ve had no eyelashes or eyebrows. I would give anything to find a way to help this problem.
PatientReceived 1 prior treatment
I have had a severe form of trikotilomania since I was 9 years old ,will probably have it the rest of my life ,but I would like to be able to take part in finding a cure ,so other young people won't have to endure the suffering this problem has caused me.
PatientReceived 1 prior treatment
I have tried medications, supplements, therapy, etc and nothing works. This causes me great emotional distress and hurts my self confidence. My TTM developed post partum with my second child at age 37. This birth coincided with a period of significant trauma.
PatientReceived 2+ prior treatments
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