CompletedPhase 2

A Study in Patients With Trichotillomania

United States128 participantsStarted 2018-12-19

Plain-language summary

The purpose of this study is to explore the safety, tolerability and activity of SXC-2023 when dosed for 6 weeks versus placebo in adult patients with moderate to severe Trichotillomania.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. Adult, female or male, 18-45 years of age, inclusive at screening.
✓. Provided signed written informed consent with willingness and ability to comply with all aspects of the protocol.
✓. Diagnosis of current TTM based on Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria and confirmed using the clinician-administered MINI-TTM. In addition, subjects should:
✓. Have a history of TTM for at least one year
✓. Have a history of daily hair pulling for at least 6 months prior to the first dose
✓. Except for SSRIs or SNRIs, has not used any psychoactive medications including, but not limited to, other antidepressants, anxiolytics, mood stabilizers, anti-psychotics, benzodiazepines, stimulants, sulfasalazine, and St. John's Wort 30 days prior to first dose. Subjects will be allowed to maintain background therapy with SSRIs or SNRIs if on stable regimen for a minimum of 90 days prior to first dose and there are no anticipated changes to the SSRI/SNRI during course of trial.
✓. Has not used N-acetylcysteine for at least 90 days prior to the first dose.
✓. Has not used gemfibrozil or repaglinide for 1 week prior to the first screening visit.

Exclusion criteria

✕. Females who are pregnant or breastfeeding or intend to become pregnant during the study period or within 30 days of the final dose of study drug.
✕. Subjects engaged in cognitive behavioral therapy (CBT) for TTM or other body-focused repetitive behavior or any obsessive-compulsive related or impulse control disorder any time within 60 days prior to first dose. For other psychotherapies, subject must have been engaged in that psychotherapy for a minimum of 60 days at the time of first dose and must be willing to maintain the same frequency and type of therapy for the duration of the study period.
✕. Subjects engaged in any other behavioral interventions (e.g., wearable devices, behavioral self-help strategies) within 60 days prior to first dose.
✕. Mentally or legally incompetent.
✕. Suffered a concussion in the past 6 months prior to screening. Any history of traumatic brain injury with loss of consciousness in the year prior to first screening visit.
✕. Any lifetime history of any psychotic disorder, including schizophrenia or any bipolar or bipolar-related disorder as determined by clinical history or confirmed at screening with the MINI, version 7.0.2.
✕. Current major depressive episode confirmed at screening with the MINI, version 7.0.2.
✕. Per PI judgment, the presence of any emotional problems or psychiatric disorders that may obscure evaluation of primary TTM or pose a risk to subject safety or stability during the study period. Other emotional problems or diagnoses may include, but are not limited to, other body-focused repetitive behaviors, post-traumatic stress disorder, obsessive-compulsive disorder, panic disorder, compulsive gambling, borderline personality disorder, or antisocial personality disorder.

What they're measuring

Explore the incidence of treatment-emergent adverse events in adults with moderate to severe TTM

Timeframe: Up to 7 weeks

Trial details

NCT IDNCT03797521

SponsorPromentis Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-02

View on ClinicalTrials.gov More Trichotillomania trials