A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Titration Study to Assess the Safety, Tolerability, and Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults
Yale University
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.
Description
Eligible subjects will be randomized in a double-blind manner in a 1:1 ratio to once-daily doses of valbenazine or placebo for 12 weeks. After week 12, all subjects will begin the 12-week, open-label portion of the study in which they all get their optimal dose. Follow-up assessments will be conducted at the end of week 26 (2 weeks after the last dose of the study drug). For subjects randomized to active treatment, the starting dose will be valbenazine 40mg, which may be escalated to 80mg to achieve an optimal dose of valbenazine for each subject. Dose escalation will occur at the end of week…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 (ma…
Interventions
- DrugValbenazine Oral Capsule
Participants randomized to active treatment will be given a starting dose of 40mg of valbenazine , which may be escalated to 80mg to achieve an optimal dose of the medication for each subject.
- OtherPlacebo Oral capsule
Participants randomized to placebo will be given a capsule that is the same shape and color as the active medication and will subject to the same dose escalation requirements as the other arm but will receive placebo during the treatment period.
Location
- Yale Child Study CenterNew Haven, Connecticut