Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Valbenazine Oral Capsule
- Placebo Oral capsule
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
Neurocrine Biosciences
Collaborator
Source ClinicalTrials.gov