A Study in Patients With Trichotillomania

Therapuetic Areas:Psychiatry / Psychology
Age Range:18 - 45
Start Date:December 19, 2018
End Date:January 15, 2020

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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

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

This is a Phase 2, multicenter, double-blind, placebo-controlled, parallel-group study
consisting of a screening period of up to 30 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

Patients will be randomized to one of four treatment groups. Patients will participate for a
total of up to 9 weeks, including screening, the 6-week treatment period and follow-up.

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

4. Except for SSRIs and SNRIs, has not used any psychoactive medications including, but
not limited to, other antidepressants, anxiolytics, mood stabilizers, anti-psychotics,
benzodiazepines, sulfasalazine, and over-the-counter/herbal psychoactive drugs (e.g.,
melatonin, St. John's Wort), for 30 days prior to first screening visit. 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 screening visit.

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 methods:

- Hormonal contraception or non-hormone releasing intrauterine device used for at
least 3 months prior to the first dosing and with either a physical (e.g.,
condom, diaphragm, or other) 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.

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

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. 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 30 days prior to first screening visit. For other psychotherapies, subject must
have been engaged in that psychotherapy for a minimum of 4 weeks at time of first
screening visit and must be willing to maintain the same frequency and type of therapy
for the duration of the study period.

3. Engaged in any other behavioral interventions (e.g., wearable devices, behavioral
self-help strategies) within 60 days of the first screening visit.

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

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. 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

11. 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.

12. 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.

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

14. 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
We found this trial at
Oklahoma City, Oklahoma 73103
Phone: 405-235-8188
Oklahoma City, OK
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185 Cambridge Street
Boston, Massachusetts 02114
Principal Investigator: Lisa Zakhary, MD PhD
Phone: 617-643-8464
Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
Phone: 773-834-3778
University of Chicago One of the world's premier academic and research institutions, the University of...
Chicago, IL
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Brooklyn, New York 11229
Phone: 718-444-7774
Brooklyn, NY
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Charleston, South Carolina 29405
Phone: 843-576-6750
Charleston, SC
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Decatur, Georgia 30030
Phone: 404-537-1281
Decatur, GA
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Lake Charles, Louisiana 70601
Principal Investigator: Yadalam, MD
Phone: 337-564-6405
Lake Charles, LA
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North Miami, Florida 33021
Phone: 305-722-8444
North Miami, FL
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Pico Rivera, California 90660
Phone: 562-928-8601
Pico Rivera, CA
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11748 Magnolia Avenue
Riverside, California 92503
Phone: 951-371-1190
Riverside, CA
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Rochester, New York 14618
Phone: 585-241-3243
Rochester, NY
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Shaker Heights, Ohio 44122
Phone: 216-832-6606
Shaker Heights, OH
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