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临床试验/NCT04932291
NCT04932291已完成2 期

"A Double-blind, Randomized, Placebo-controlled, Adaptive 14-week Phase IIb Trial to Evaluate the Efficacy and Safety of Vafidemstat in an Adult Borderline Personality Disorder (BPD) Population (PORTICO)"

Oryzon Genomics S.A.21 个研究点 分布在 5 个国家目标入组 211 人开始时间: 2021年3月26日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
211
试验地点
21
主要终点
Efficacy: Difference in the CGI-S A/A From Baseline to Average of Weeks 8 to 12
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

PORTICO is a Phase IIb study to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population.

详细描述

PORTICO is a double blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Main inclusion criteria:
  • •Men and women 18-65 years of age.
  • •DSM-5 diagnostic criteria for BPD at least 3 months before the Screening visit. The Mini-International Neuropsychiatric Interview (MINI) will be administered at screening in order to confirm BPD diagnosis, as well as to confirm subject does not meet other relevant

排除标准

  • •Agitation-Aggression Psychiatric Inventory-Clinician Report (AAPI-CR) Agitation & Aggression (A/A) subscale score of ≥ 16 (severity x frequency) summed across the four (4) items comprising the A/A subscale, and the sum of the A/A subscale severity scores ≥
  • •Stable living environment for > 6 months before the Screening visit.
  • •Body mass index (BMI) of at least 18.5 kg/m2, but no more than 35 kg/m
  • •Willing and able to adhere to the prohibitions, restrictions and requirements specified in this protocol.
  • •Otherwise, healthy, and medically stable based on medical history.
  • •Clinical and neurological examinations and laboratory tests, as well as 12-lead ECG performed during screening that confirms subject is healthy and medically stable.
  • •Able to read and write fluently and must have adequate hearing and visual acuity to complete the required testing outlined in this protocol.
  • •Stable in their permitted regimen of background therapy as per drug labeling for concomitant medications at the Screening visit and they should maintain treatment throughout the study and not initiate any prohibited medications during the trial. Subjects should agree to inform their study physician of any medication changes throughout the trial.
  • •Enrolled subjects will need to maintain their pre-screening psychotherapy schedule throughout the trial duration. That is, subjects receiving psychotherapy will need to have it started at least 3 months before the Screening visit and remain in psychotherapy throughout the trial. Subjects not receiving psychotherapy should not initiate psychotherapy during the trial.
  • •Fertile male and female subjects must use highly efficient contraception, from the Screening visit until 30 days after last dose of the IMP, defined as:
  • •A method with less than 1% failure rate (e.g., permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner) OR The use of two methods of contraception (e.g., one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive [e.g., combined oral contraceptives, patch, vaginal ring, injectable and implants])
  • •Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline.
  • •Signed informed consent by participant prior to the initiation of any study specific procedure.
  • •Main exclusion criteria
  • •Failure to perform screening or baseline procedures.
  • •DSM-5 diagnosis of intellectual disability, autism spectrum disorder, schizophrenia, schizoaffective disorder, bipolar disorder (or related disorders) or major depressive disorder (MDD) with psychosis.
  • •Current DSM-5 diagnosis of conduct disorder, anorexia nervosa, bulimia nervosa, binge-eating disorder, oppositional defiant disorder, paranoid personality disorder or obsessive-compulsive disorder.
  • •Current DSM-5 diagnosis of panic disorder or post-traumatic stress disorder (PTSD). However, subjects with PTSD, generalized anxiety disorder (GAD), social anxiety disorder (SAD), MDD without psychosis, attention deficit hyperactivity disorder (ADHD) are eligible if symptoms have been stable for at least 90 days prior to the Screening visit, these disorders are not the primary focus of treatment, changes in any treatment for these disorders would not likely be required for the duration of the study, and in the investigator´s opinion these disorders will not interfere with the assessment and/or accuracy of the study endpoints.
  • •History of moderate or severe substance or alcohol use disorder according to DSM-5, with the exception of nicotine and caffeine, within 6-months before screening.
  • •Use of illicit drugs for at least one week before Screening and subjects unwilling to abstain from use of these substances during the study. Use of alcohol or cannabinoids is not allowed within 24 hours prior to a study visit. Regarding cannabis, patient self-report of abstinence within 24 hours will be used for inclusion decision-making versus the urine drug test results.
  • •Hospitalization or medication change for any reason, two months prior to the Screening visit or during the Screening period, that makes the subject medically or mentally unsuitable for trial participation.
  • •Clinically significant, advanced or unstable disease that is likely to result in rapid deterioration of the subject's condition or affect their safety during the study.
  • •Positive results for tuberculosis, Human Immunodeficiency Virus (HIV), Hepatitis C or Hepatitis B serology obtained at the Screening Visit.
  • •Uncontrolled hypo- or hyperthyroidism at Screening Visit, based on laboratory parameters.
  • •Clinically significant infection within the previous 30-days.
  • •Chronic drug intake of specific forbidden medication
  • •Esketamine in the past 90 days before the Screening visit.
  • •Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in the past 90 days before the screening visit.
  • •Any regular intake of medications acting directly on central nervous system that investigator considers relevant to the study.
  • •Member or immediate family of the study personnel or subordinate to any of the study personnel.
  • •Enrollment in another investigational study or intake of investigational drug within the previous 3 months.
  • •Suicide attempt within the 6-month prior to the Screening visit or significant risk of suicide.
  • •Any condition that in the opinion of the investigator makes the subject unsuitable for inclusion in the study.

研究组 & 干预措施

placebo

Placebo Comparator

Placebo is administered as capsules.

干预措施: Placebo (Drug)

vafidemstat 1.2mg

Experimental

Vafidemstat is administered as capsules.

干预措施: vafidemstat (Drug)

结局指标

主要结局

Efficacy: Difference in the CGI-S A/A From Baseline to Average of Weeks 8 to 12

时间窗: From Baseline-Week 0 to average of Weeks 8 to 12

Change on the CGI-S A/A from Baseline to average of Weeks 8 to 12, between the active treatment arm (Vafidemstat 1.2 mg) and the placebo arm (full analysis set). * Full scale name: Clinical Global Impression-Severity focused on Agitation/Aggression * Scale construct: the CGI-S A/A is a clinician's global rating of the BPD patients' severity of agitation and aggression symptoms at the time of evaluation. * Scale items: 1. * Scale range values: 0 to 7. Higher scores reflect greater severity of BPD-related agitation and agression symptoms. * Scale score: 0 (min) - 7 (max).

Efficacy: Difference in the BPDCL-Total Score From Baseline to Average of Weeks 8 to 12

时间窗: From Baseline-Week 0 to average of Weeks 8 to 12

Change on the BPDCL-Total Score from Baseline to average of Weeks 8 to 12, between the active treatment arm (Vafidemstat 1.2 mg) and the placebo arm (full analysis set). * Full scale name: Borderline Personality Disorder Checklist. * Scale construct: the BPDCL is a patient-reported outcome measure of BPD symptoms' severity over the past 2 weeks. The Total Score is a global score representing overall BPD symptom burden. * Scale items: 47 items. * Scale range values: 1 to 5 for each item. * Scale score: Total Score=47 (min) - 235 (max) as the sum of the 47 items scores. Higher scores reflect greater severity of BPD symptoms.

次要结局

  • Efficacy: Difference in the BEST-Total Score From Baseline to Average of Weeks 8 to 12(From Baseline-Week 0 to average of Weeks 8 to 12)
  • Efficacy: Difference in the BDI-II Total Score From Baseline to Average of Weeks 8 to 12(From Baseline-Week 0 to average of Weeks 8 to 12)
  • Efficacy: Difference in the STAXI-2-State Anger Subscale Score From Baseline to Average of Weeks 8 to 12(From Baseline-Week 0 to average of Weeks 8 to 12)
  • Efficacy: Difference in the STAXI-2-Trait Anger Subscale Score From Baseline to Average of Weeks 8 to 12(From Baseline-Week 0 to average of Weeks 8 to 12)
  • Efficacy: Difference in the STAXI-2-Anger Expression Index Subscale Score From Baseline to Average of Weeks 8 to 12(From Baseline-Week 0 to average of Weeks 8 to 12)
  • Efficacy: Difference in the STAI-State Anxiety From Baseline to Average of Weeks 8 to 12(From Baseline-Week 0 to average of Weeks 8 to 12)
  • Efficacy: Difference in the CGI-S A/A Over Time (From Baseline to Week 12)(From Baseline-Week 0 to Week 12)
  • Efficacy: Difference in the STAXI 2-State Anger Subscale Score Over Time (From Baseline to Week 12)(Over time: from Baseline-Week 0 to Week 12)
  • Efficacy - Difference in the BPDCL-Total Score Over Time (From Baseline to Week 12)(Over time: from Baseline-Week 0 to Week 12)
  • Efficacy: Difference in the BEST-Total Score Over Time (From Baseline to Week 12)(Over time: from Baseline-Week 0 to Week 12)
  • Efficacy - Difference in the BDI-II Total Score Over Time (From Baseline to Week 12)(Over time: from Baseline-Week 0 to Week 12)
  • Efficacy: Difference in the STAXI 2-Trait Anger Subscale Score Over Time (From Baseline to Week 12)(Over time: from Baseline-Week 0 to Week 12)
  • Efficacy: Difference in the STAXI 2-Anger Expression Index Subscale Score Over Time (From Baseline to Week 12)(Over time: from Baseline-Week 0 to Week 12)
  • Efficacy: Difference in the STAI-State Anxiety Over Time (From Baseline to Week 12)(Over time: from Baseline-Week 0 to Week 12)
  • Efficacy: Difference in the STAI-Trait Anxiety Over Time (From Baseline to Week 12)(Over time: from Baseline-Week 0 to Week 12)
  • Safety: Number of Subjects Experiencing Treatment-emergent Adverse Events (TEAEs)(From Baseline-Week 0 to Week 14)

研究者

发起方
Oryzon Genomics S.A.
申办方类型
Industry
责任方
Sponsor

研究点 (21)

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