Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults (NCT05207085) | Clinical Trial Compass
RecruitingPhase 2
Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults
United States20 participantsStarted 2024-02-02
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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).
✓. Female subjects must have a negative urine pregnancy test at screening, baseline and weeks 2, 4, 8, 12, 14, 16, 20, 24 and 26.
What they're measuring
1
Change in Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to Week 12
✓. Negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates) at screening, baseline and weeks 2, 4, 8, 12, 14, 16, 20, 24 and 26. Subjects on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates or psychostimulants (participants with ADHD) can participate in the study. Results from a positive drug screen will be discarded.
✓. 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.
Exclusion criteria
✕. 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).
✕. 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.
✕. Positive pregnancy test or drug screening test.