A Study in Patients With Trichotillomania

Phase 2

Completed

• Conditions: Trichotillomania
• Interventions: Drug: SXC-2023; Drug: Placebo

• Registration Number: NCT03797521
• Lead Sponsor: Promentis Pharmaceuticals, Inc.

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.

Detailed Description

This is a Phase 2, multicenter, double-blind, placebo-controlled, parallel-group study consisting of a screening period of up to 40 days, a 6 week randomized double-blind treatment period, followed by an up to 2 week safety follow-up period after the last dose of study medication.

Patients will be randomized to one of four treatment groups. Patients will participate for a total of up to 10 weeks, including screening, the 6-week treatment period and follow-up.

Study Timeline

• Study Start: 2018-12-19
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-09
• Primary Completion: 2019-12-02
• Study Completion: 2019-12-16
• Disposition First Submitted: 2020-12-11
• Status Verified: 2021-10
• Disposition First Submitted QC: 2021-10-26
• Last Update Submitted: 2021-10-26
• Disposition First Posted: 2021-10-28
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

Exclusion Criteria

1. 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.

2. 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.

3. Subjects engaged in any other behavioral interventions (e.g., wearable devices, behavioral self-help strategies) within 60 days prior to first dose.

4. Mentally or legally incompetent.

5. 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.

6. 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.

7. Current major depressive episode confirmed at screening with the MINI, version 7.0.2.

8. 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.

9. 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.

10. Laboratory evidence of renal impairment (e.g. a creatine clearance of < 80)

11. 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.

12. 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.

13. Subjects with any of the following:

    1. Any psychiatric hospitalizations in the past year,
    2. Imminent risk of suicide based on PI's or designee's clinical judgment or psychiatric examination,
    3. Active suicidal ideation in the past 6 months as evidenced by positive endorsement to Item 4 or 5 on the C-SSRS, OR
    4. Any history of suicidal behavior in the past year as evidenced by positive endorsement to any of the suicidal behavior items on the C-SSRS.

14. Has previously participated in any Promentis Phase 1 study.

15. Participation in another interventional clinical study (including CBT or other behavioral intervention) within 30 days prior to the first screening visit. The 30 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to the date of initiation of screening in the current study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SXC-2023 200mg QD	SXC-2023	SXC-2023 200mg dosed once daily for 6 weeks
Matching Placebo QD	Placebo	Matching Placebo dosed once daily for 6 weeks
SXC-2023 50mg QD	SXC-2023	SXC-2023 50mg dosed once daily for 6 weeks
SXC-2023 800mg QD	SXC-2023	SXC-2023 800mg dosed once daily for 6 weeks

Primary Outcome Measures

Name	Time	Method
Explore the incidence of treatment-emergent adverse events in adults with moderate to severe TTM	Up to 7 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Preliminary psychometric evidence of the Trichotillomania Symptom Diary (TSD) will be assessed	Up to 7 weeks	The reliability, validity and responsiveness of the newly developed TSD assessment will be assessed at the item level.
Change from baseline hairpulling frequency and severity daily through 6 weeks	Up to 7 weeks	Improvement will be assessed using the different measurement parameters of all scales using scales such as the Trichotillomania Symptom Diary (TSD)
Change from baseline hairpulling frequency and severity through 6 weeks	Up to 7 weeks	Improvement will be assessed using the different measurement parameters of all scales using scales such as the Patient Global Impression of Status and Change (PGI-S/C)

Trial Locations

Locations (13)

Finger Lakes Clinical Research; 🇺🇸 Rochester, New York, United States

Integrative Clinical Trials, LLC; 🇺🇸 Brooklyn, New York, United States

Artemis Institute for Clinical Research; 🇺🇸 Riverside, California, United States

iResearch Atlanta; 🇺🇸 Decatur, Georgia, United States

CNRI- Los Angeles; 🇺🇸 Pico Rivera, California, United States

IPS Research Company; 🇺🇸 Oklahoma City, Oklahoma, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Behavioral Clinical Research; 🇺🇸 North Miami, Florida, United States

Univ of Chicago; 🇺🇸 Chicago, Illinois, United States

Lake Charles Clinical Trials; 🇺🇸 Lake Charles, Louisiana, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

Insight Clinical Trials, LLC; 🇺🇸 Shaker Heights, Ohio, United States

Carolina Clinical Trials, Inc; 🇺🇸 Charleston, South Carolina, United States