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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Valbenazine Oral Capsule
DrugParticipants 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 interventionParticipants 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: ValbenazineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to Week 12
Massachusetts General Hospital Hairpulling Scale (MGH-HPS) scores range from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 12 weeks.
Time frame
baseline to week12Secondary outcomes
1
Clinical Global Improvement Scale - Trichotillomania Severity (CGI-TTM) score at endpoint
Each of the Clinical Global Improvement Scale -Trichotillomania (CGI-TTM) response categories was assigned a numerical score as follows: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = Not changed; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse. Responder status on Clinical Global Improvement Scale as having a CGI-TTM score at endpoint less than or equal to 2.
Time frame
Week 12Sponsors and contacts
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Yale University
Lead sponsor
Neurocrine Biosciences
Collaborator
Source ClinicalTrials.gov