| Eligibility |
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.
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