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Tests treatment safety and results for Trichotillomania (Hair-Pulling Disorder)
Official title Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults
ClinicalTrials.gov ID: NCT05207085
What this study is testing
What is Valbenazine Oral Capsule?
Valbenazine Oral Capsule is an investigational medicine, given as an once-daily, being studied as a potential treatment for trichotillomania (hair-pulling disorder).
Also referred to as Ingrezza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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.
- people of child-bearing potential must agree to use contraception (condoms for men, birth control pill or diaphragm for women) consistently from...
You likely can't join 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...
- 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...
- Positive pregnancy test or drug screening test.
See the full eligibility criteria
- 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.
- people 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...
- Female people 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. people on stable doses of...
- 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.
- 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...
- 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...
- 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.
- Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (e.g., tetrabenazine).
- Have a history of or suspected poor compliance in clinical research studies.
- Have previous experience with valbenazine or previously participated in a valbenazine clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.