A Study in Patients With Trichotillomania

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Brief Title

A Study in Patients With Trichotillomania

Official Title

A Phase 2, Double Blind, Placebo-Controlled Study to Explore the Safety, Tolerability, and Activity of SXC-2023 in Adults With Moderate to Severe Trichotillomania (TTM) When Dosed for 6 Weeks

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Change from baseline hairpulling frequency and severity through 6 weeks

Condition

Trichotillomania

Intervention

SXC-2023

Study Arms / Comparison Groups

 SXC-2023 50mg QD
Description:  SXC-2023 50mg dosed once daily for 6 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

128

Start Date

December 19, 2018

Completion Date

December 16, 2019

Primary Completion Date

December 2, 2019

Eligibility Criteria

        Inclusion Criteria

          1. Adult, female or male, 18-45 years of age, inclusive at screening.

          2. Provided signed written informed consent with willingness and ability to comply with
             all aspects of the protocol.

          3. 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:

               1. Have a history of TTM for at least one year

               2. Have a history of daily hair pulling for at least 6 months prior to the first
                  dose

          4. 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.

          5. Has not used N-acetylcysteine for at least 90 days prior to the first dose.

          6. Has not used gemfibrozil or repaglinide for 1 week prior to the first screening visit.

          7. 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.

          8. 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.

             In addition, female subjects of childbearing potential will be advised to remain
             sexually inactive or to keep the same birth control method for at least 30 days
             following the last dose.

          9. Female of non childbearing potential: must have undergone one of the following
             sterilization procedures, at least 6 months prior to the first dose:

               -  hysteroscopic sterilization;

               -  bilateral tubal ligation or bilateral salpingectomy;

               -  hysterectomy;

               -  bilateral oophorectomy; Or be postmenopausal with amenorrhea for at least 1 year
                  prior to the first dose with serum follicle stimulating hormone levels consistent
                  with postmenopausal status or have medically documented history of biological or
                  congenital sterility.

         10. A non vasectomized, male subject must agree to use a condom with spermicide or abstain
             from sexual intercourse during the study until 30 days beyond the last dose of study
             drug/placebo.

         11. If male, must agree not to donate sperm from the first dose until 30 days after the
             last dose administration.

         12. Must be able to fluently read and write in English.

         13. Understands the study procedures in the informed consent form (ICF) and is willing and
             able to comply with the protocol.

        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.
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Tricia Pimentel Cotter, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03797521

Organization ID

PRO-201


Responsible Party

Sponsor

Study Sponsor

Promentis Pharmaceuticals, Inc.


Study Sponsor

Tricia Pimentel Cotter, Study Director, Promentis Pharmaceuticals


Verification Date

November 2020