EUCTR2019-002897-30-ES进行中（未招募）1 期
A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Adult Subjects With Borderline Personality Disorder
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 201
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Subjects, who completed the last treatment visit of the previous double-blind brexpiprazole BPD trial and who, in the opinion of the investigator, could potentially benefit from administration of brexpiprazole for the treatment of BPD.
- •2) Male or female outpatients, ages 18 to 65 years, inclusive, at the time of informed consent of the previous double-blind brexpiprazole BPD trial.
- •3) Subjects who are able to complete the consent process and/or consent obtained from a legally acceptable representative (as required by the institutional review board [IRB]/independent ethics committee [IEC]) prior to the initiation of any protocol-required procedures.
- •4) Ability, in the opinion of the principal investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited medication, and to read and understand the written word in order to be reliably rated on assessment scales.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 195
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Sexually active males or females of childbearing potential (FOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, intrauterine device, birth control pill, birth control implant, birth control depot injection, condom with spermicide, sponge with spermicide, or occlusive cap (vaginal diaphragm or cervical/vault cap) with spermicide. Male or female subjects identifying as homosexual with exclusively same-sex partners may not be required to practice birth control methods following discussion with the investigator and medical monitor.
- •Male subjects must also agree not to donate sperm from trial screening/baseline through 30 days after the last dose of IMP.
- •2) Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
- •3) Subjects who fulfill the following criteria related to suicide and/or suicidal ideation at entry are excluded:
- •- Subjects who have a significant risk of committing violent acts, serious self-harm, or suicide, or those who are homicidal or considered to be a high
- •risk to others, or subjects with a response of yes” on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item 5 (Active Suicidal
- •Ideation with Specific Plan and Intent), OR
- •- Subjects with a response of yes” on the C-SSRS Suicidal Behavior Items Actual Attempt, Interrupted Attempt, or Aborted Attempt
- •- Subjects who endorse engaging in preparatory acts and/or non-suicidal self-injury may be included according to investigator judgment, provided the
- •behavior has not increased significantly in frequency or severity during the preceding double-blind trial period, and after discussion and approval by the medical monitor.
- •4) Subjects with abnormal laboratory tests results, vital signs results, or electrocardiogram (ECG) findings, unless, based on the investigator’s judgment, the findings are not medically significant and would not impact the safety of the subject or the interpretation of the trial results. The medical monitor should be contacted to discuss individual cases, as needed. In addition, subjects with the following laboratory test and ECG results at
- •screening must be excluded from the trial:
- •? Platelets = 75000/mm3
- •? Hemoglobin = 9 g/dL
- •? Neutrophils, absolute = 1000/mm3
- •? Aspartate aminotransferase (AST) > 2 × the upper limit of normal (ULN)
- •? Alanine aminotransferase (ALT) > 2 × ULN
- •? Creatine phosphokinase (CPK) > 3 × ULN, unless discussed with and approved by the medical monitor
- •? Creatinine = 2 mg/dL
- •? QT interval corrected for heart rate using Fridericia’s formula (QTcF) = 450 msec in men and = 470 msec in women, unless due to ventricular
- •pacing. Tests with exclusionary results should be repeated to ensure reproducibility of the abnormality before excluding a subject based on the criteria noted above. For ECGs, perform 3 consecutive recordings. If 2 of the 3 remain exclusionary then the subject must be excluded.
研究者
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