A Study in Patients With Trichotillomania

NCT03797521 | Completed Phase 2 FDA Drug

• 1 other identifier: PRO-201
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Trichotillomania

Keywords

Promentis Pharmaceuticals; TTM; SXC-2023

Outcome Measures

Primary Outcomes (1)

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

  Safety and tolerability assessed using the frequency of subjects with serious adverse events, adverse events leading to discontinuation, and adverse events judged to be related to study medication.

  Up to 7 weeks

Secondary Outcomes (5)

• Change from baseline hairpulling frequency and severity through 6 weeks

  Up to 7 weeks

• Change from baseline hairpulling frequency and severity through 6 weeks

  Up to 7 weeks

• Change from baseline hairpulling frequency and severity through 6 weeks

  Up to 7 weeks

• Change from baseline hairpulling frequency and severity daily through 6 weeks

  Up to 7 weeks

• Preliminary psychometric evidence of the Trichotillomania Symptom Diary (TSD) will be assessed

  Up to 7 weeks

Study Arms (4)

SXC-2023 50mg QD

EXPERIMENTAL

SXC-2023 50mg dosed once daily for 6 weeks

Drug: SXC-2023

SXC-2023 200mg QD

EXPERIMENTAL

SXC-2023 200mg dosed once daily for 6 weeks

Drug: SXC-2023

SXC-2023 800mg QD

EXPERIMENTAL

SXC-2023 800mg dosed once daily for 6 weeks

Drug: SXC-2023

Matching Placebo QD

PLACEBO COMPARATOR

Matching Placebo dosed once daily for 6 weeks

Drug: Placebo

Interventions

SXC-2023 DRUG

SXC-2023 oral capsules

SXC-2023 200mg QD; SXC-2023 50mg QD; SXC-2023 800mg QD

Placebo DRUG

Matching Placebo oral capsules

Matching Placebo QD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Medically healthy with no clinically significant findings in medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the Principal Investigator (PI) or designee.
• For a female of childbearing potential: either be sexually inactive (abstinent as a life style) for 28 days prior to the first dosing and throughout the study or be using one of the following acceptable birth control options:
• Oral contraception for at least 3 months prior to the first dosing along with either a physical (e.g., condom, diaphragm) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study
• IUD (either hormone-releasing or non-hormone releasing) for at least minimum duration per current labeling along with either a physical (e.g., condom, diaphragm) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study
• Depo contraception for at least minimum duration per current labeling prior to the first dosing along with either a physical (e.g., condom, diaphragm) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study
• Double physical barrier method (e.g., condom and diaphragm) from 14 days prior to the first dose and throughout the study
• Physical plus chemical barrier method (e.g., condom with spermicide) from 14 days prior to the first dose and throughout the study.

You may not qualify if:

• 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.
• History of any injury, illness, or condition that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• Laboratory evidence of renal impairment (e.g. a creatine clearance of \< 80)
• Presence of any substance use disorder or, in the opinion of the PI or designee, problematic substance use (excluding nicotine or caffeine) within the 2 years prior to screening.
• History of seizure disorder with the exception of subjects who have been off anti-seizure medication and have not had a seizure in the past 5 years.
• Subjects with any of the following:
• Any psychiatric hospitalizations in the past year,
• Imminent risk of suicide based on PI's or designee's clinical judgment or psychiatric examination,

Sponsors & Collaborators

• Promentis Pharmaceuticals, Inc.: lead

Study Sites (13)

CNRI- Los Angeles

Pico Rivera, California, 90662, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Behavioral Clinical Research

North Miami, Florida, 33161, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Univ of Chicago

Chicago, Illinois, 60637, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Integrative Clinical Trials, LLC

Brooklyn, New York, 11229, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Insight Clinical Trials, LLC

Shaker Heights, Ohio, 44122, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Carolina Clinical Trials, Inc

Charleston, South Carolina, 29407, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Related Publications (1)

• Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.

  PMID: 34582562 DERIVED

MeSH Terms

Conditions

Trichotillomania

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Study Officials

• Dean Brostowin

  Promentis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, Placebo-controlled Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 9, 2019
• Study Start: December 19, 2018
• Primary Completion: December 2, 2019
• Study Completion: December 16, 2019
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

US (13)