Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults

Conditions

• Trichotillomania (Hair-Pulling Disorder)

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Valbenazine Oral Capsule — DRUG
  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.
• Placebo Oral capsule — OTHER
  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.

Study Details

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.

Key Dates

Start date

Feb 2, 2024

Status verified

Jan 2026

Primary completion

Feb 15, 2027

Completion

Feb 15, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Valbenazine
  Participants randomized1:1 to receive valbenazine
• Placebo Comparator: Placebo
  Participants randomized 1:1 to receive placebo

Primary Outcome Measure

Change in Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to Week 12 [ Time Frame: baseline to week12 ]

Central Contacts

• Angeli Landeros, MD
  203737-4539
  [email protected]

Locations (1)

Find similar trials in New Haven, CT

Related Studies

• Aripiprazole in Body Focused Repetitive Behaviors
  PHASE2 · Not Yet Recruiting · University of Chicago · Chicago, Illinois