TrichotillomaniaPhase 2TTMNCT03797521
A Study in Patients With Trichotillomania
A Phase 2 study testing SXC-2023 in people with Trichotillomania, run by Promentis Pharmaceuticals, Inc. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Trichotillomania
- What is being tested?
- SXC-2023
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 13 sitesUnited States
- Study dates
- 19 Dec 2018to 16 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
- 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.
- 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.
- 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.
- If male, must agree not to donate sperm from the first dose until 30 days after the last dose administration.
- Must be able to fluently read and write in English.
- Understands the study procedures in the informed consent form (ICF) and is willing and able to comply with the protocol.
Who cannot join
- 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.
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- 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,
- Active suicidal ideation in the past 6 months as evidenced by positive endorsement to Item 4 or 5 on the C-SSRS, OR
- 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.
- Has previously participated in any Promentis Phase 1 study.
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Northwest Clinical Research Center
Bellevue, Washington, 98007
Massachusetts General Hospital
Boston, Massachusetts, 02114
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229
Carolina Clinical Trials, Inc
Charleston, South Carolina, 29407
Univ of Chicago
Chicago, Illinois, 60637
iResearch Atlanta
Decatur, Georgia, 30030
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629
Behavioral Clinical Research
North Miami, Florida, 33161
IPS Research Company
Oklahoma City, Oklahoma, 73103
CNRI- Los Angeles
Pico Rivera, California, 90662
Artemis Institute for Clinical Research
Riverside, California, 92503
Finger Lakes Clinical Research
Rochester, New York, 14618
Insight Clinical Trials, LLC
Shaker Heights, Ohio, 44122
About this study
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
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.
Read the 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.
- Conditions
- Trichotillomania
- Being tested
- SXC-2023, Placebo
- Keywords
- Promentis Pharmaceuticals, TTM, SXC-2023
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SXC-2023Drug
SXC-2023 oral capsules
PlaceboDrug
Matching Placebo oral capsules
| Study group | Role | What they receive |
|---|---|---|
| SXC-2023 50mg QD | Experimental | SXC-2023 50mg dosed once daily for 6 weeks Receives: Drug: SXC-2023 |
| SXC-2023 200mg QD | Experimental | SXC-2023 200mg dosed once daily for 6 weeks Receives: Drug: SXC-2023 |
| SXC-2023 800mg QD | Experimental | SXC-2023 800mg dosed once daily for 6 weeks Receives: Drug: SXC-2023 |
| Matching Placebo QD | Placebo comparator | Matching Placebo dosed once daily for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 weeks
Secondary outcomes (5)
Change from baseline hairpulling frequency and severity through 6 weeks
Improvement will be assessed using the different measurement parameters of all scales using scales such as the Massachusetts General Hospital Hairpulling scale (MGH-HPS)
Measured: Up to 7 weeks
Change from baseline hairpulling frequency and severity through 6 weeks
Improvement will be assessed using the different measurement parameters of all scales using scales such as the Clinical Global Impression of Severity and Change (CGI-S/C)
Measured: Up to 7 weeks
Change from baseline hairpulling frequency and severity through 6 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)
Measured: Up to 7 weeks
Change from baseline hairpulling frequency and severity daily through 6 weeks
Improvement will be assessed using the different measurement parameters of all scales using scales such as the Trichotillomania Symptom Diary (TSD)
Measured: Up to 7 weeks
Preliminary psychometric evidence of the Trichotillomania Symptom Diary (TSD) will be assessed
The reliability, validity and responsiveness of the newly developed TSD assessment will be assessed at the item level.
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start19 Dec 2018
- Primary completion2 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TrichotillomaniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promentis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dean Brostowin, Study director, Promentis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797521
- Sponsor's protocol ID
- PRO-201
- Acronym
- TTM
- Status last verified
- Oct 2021
- First submitted
- 2 Jan 2019
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 34582562
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03797521
- Acronym / sponsor ID
- TTM / PRO-201
- Conditions
- Trichotillomania
- Keywords
- Promentis Pharmaceuticals, TTM, SXC-2023
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Promentis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SXC-2023 50mg QD | Experimental | Drug: SXC-2023SXC-2023 50mg dosed once daily for 6 weeks |
| SXC-2023 200mg QD | Experimental | Drug: SXC-2023SXC-2023 200mg dosed once daily for 6 weeks |
| SXC-2023 800mg QD | Experimental | Drug: SXC-2023SXC-2023 800mg dosed once daily for 6 weeks |
| Matching Placebo QD | Placebo comparator | Drug: PlaceboMatching Placebo dosed once daily for 6 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- 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:
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SXC-2023SXC-2023 oral capsules | Drug | SXC-2023 200mg QD, SXC-2023 50mg QD, SXC-2023 800mg QD |
| PlaceboMatching Placebo oral capsules | Drug | Matching Placebo QD |
Primary outcome
Explore the incidence of treatment-emergent adverse events in adults with moderate to severe TTM
Time frame: 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.
5 secondary outcomes
Change from baseline hairpulling frequency and severity through 6 weeks
Time frame: Up to 7 weeks
Change from baseline hairpulling frequency and severity through 6 weeks
Time frame: Up to 7 weeks
Change from baseline hairpulling frequency and severity through 6 weeks
Time frame: Up to 7 weeks
Change from baseline hairpulling frequency and severity daily through 6 weeks
Time frame: Up to 7 weeks
Preliminary psychometric evidence of the Trichotillomania Symptom Diary (TSD) will be assessed
Time frame: Up to 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Derived from this study: PubMed 34582562Hoffman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean Brostowin study director
Promentis Pharmaceuticals
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SXC-2023 in people with Trichotillomania, run by Promentis Pharmaceuticals, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore the incidence of treatment-emergent adverse events in adults with moderate to severe TTM (time frame: Up to 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03797521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.