Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults

Launched by YALE UNIVERSITY · Jan 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called valbenazine to help adults with trichotillomania, which is a condition where people feel compelled to pull out their hair. Over a period of 12 weeks, participants will take either 40mg or 80mg of valbenazine once a day to see if it reduces their hair-pulling behavior compared to a placebo (a pill with no active medication). After this initial phase, there will be an additional 12 weeks where everyone will continue taking valbenazine. The main goal is to measure how much participants' symptoms improve by using a specific scale that tracks hair-pulling behaviors.

To join the trial, participants need to be adults aged 18 to 65 who are in good health and have been stable on their psychiatric medications for at least four weeks. They should have significant distress from their hair-pulling symptoms and meet certain criteria for trichotillomania. Participants will be closely monitored throughout the study and must agree to follow all the study procedures. It’s important to know that individuals with certain other mental health conditions, recent changes in their medications, or specific health issues may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Have documentation of written and witnessed consent from the subject.
• • 2. Male or female adult between the ages of 18-65, inclusive.
• • 3. Be in good health as determined by medical history, physical examination, laboratory assessments and 12-lead ECG.
• • 4. On stable psychiatric medication regime of 4 weeks prior to beginning the trial and not anticipating changes during the trial.
• • 5. 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).
• • 6. Female subjects must have a negative urine pregnancy test at screening, baseline and weeks 2, 4, 8, 12, 14, 16, 20, 24 and 26.
• • 7. 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.
• • 8. 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.
• • 9. Have symptoms that cause marked distress or significant impairment in occupational and/or social function.
• • 10. Have a stable psychiatric status (TTM) as clinically determined by the investigator.
• • 11. Meet DSM-5 criteria for TTM.
• • 12. Significant current TTM symptoms: 12 or greater score on MGH-HPS.
• Exclusion Criteria:
• • 1. Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ\<70).
• • 2. 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.
• • 3. Currently taking antipsychotic medications or other medications that affect the dopamine system (e.g. psychostimulant medications).
• • 4. Recent changes in behavior treatment (less than 4 weeks) or initiation of therapy (within 12 weeks) for TTM/Obsessive Compulsive Disorder (OCD).
• • 5. 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.
• • 6. Positive pregnancy test or drug screening test.
• • 7. Currently pregnant or lactating.
• • 8. Significant medical comorbidity.
• • 9. 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.
• • 10. History of substance (drug or alcohol) dependence or abuse within 3 months before Baseline, as defined by DSM-5 criteria for Substance Use Disorder.
• • 11. Known history of neuroleptic malignant syndrome.
• • 12. Known history of long QT syndrome or cardiac arrhythmia.
• • 13. 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.
• • 14. Have a blood loss ≥250 mL or donated blood within 56 days or donated plasma within 7 days of Day 1 (baseline).
• • 15. Have a significant risk of suicidal or violent behavior based on prior medical history and clinical judgement.
• • 16. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (e.g., tetrabenazine).
• • 17. Have a history of or suspected poor compliance in clinical research studies.
• • 18. Have previous experience with valbenazine or previously participated in a valbenazine clinical study.