NCT03797521已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 13
- 主要终点
- Explore the incidence of treatment-emergent adverse events in adults with moderate to severe TTM
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind, Placebo-controlled Study
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
- •Current major depressive episode confirmed at screening with the MINI, version 7.0.
- •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.
研究组 & 干预措施
SXC-2023 50mg QD
Experimental
SXC-2023 50mg dosed once daily for 6 weeks
干预措施: SXC-2023 (Drug)
SXC-2023 200mg QD
Experimental
SXC-2023 200mg dosed once daily for 6 weeks
干预措施: SXC-2023 (Drug)
SXC-2023 800mg QD
Experimental
SXC-2023 800mg dosed once daily for 6 weeks
干预措施: SXC-2023 (Drug)
Matching Placebo QD
Placebo Comparator
Matching Placebo dosed once daily for 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Explore the incidence of treatment-emergent adverse events in adults with moderate to severe TTM
时间窗: 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.
次要结局
- Preliminary psychometric evidence of the Trichotillomania Symptom Diary (TSD) will be assessed(Up to 7 weeks)
- Change from baseline hairpulling frequency and severity daily through 6 weeks(Up to 7 weeks)
- Change from baseline hairpulling frequency and severity through 6 weeks(Up to 7 weeks)
研究者
研究点 (13)
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