Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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. During the open-label portion of the study, all subjects will receive the study drug at their optimal dose. The primary endpoint of these studies will be the change from baseline of placebo vs. active scores utilizing the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) at the end of Week 12.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Bloch
• Collaborator: Neurocrine Biosciences

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 Day 1 (baseline).

7. Negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates or cannabinoids) at screening and baseline. Subjects on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates or psychostimulants (participants with ADHD) can participate in the study.

8. Subjects must have a negative alcohol breath test at screening and at Day 1 (baseline).

9. 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

10. Have symptoms that cause marked distress or significant impairment in occupational and/or social function

11. Have a stable psychiatric status (TTM) as clinically determined by the investigator.

12. Meet DSM-5 criteria for TTM

13. Significant current TTM symptoms: 17 or greater score on NIMH-TSS/TIS

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(33) (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