NCT02684279已完成3 期
An Open-label, Flexibly-dosed, Multicenter, Extension Study of Dasotraline to Evaluate Long-term Safety and Tolerability in Adults With Binge-eating Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 533
- 试验地点
- 52
- 主要终点
- Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
Binge Eating Disorder Extension Study.
详细描述
This is a Phase 3, 12 month, multicenter, open-label, flexibly-dosed, safety study in adults with Binge Eating Disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open-label
入排标准
- 年龄范围
- 18 Years 至 56 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the treatment period of a dasotraline core study (ie, SEP360 221 or SEP360-321) for the treatment of BED.
- •Subject has agreed to participate by providing written informed consent and is willing and able to comply with the protocol, in the opinion of the investigator.
- •Subject has not taken any medication other than the study drug for the purpose of controlling BED symptoms during the core study.
- •Female subject must have a negative urine pregnancy test at open label (OL) Baseline; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
- •Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control (see Section 22, Appendix III) throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended for 30 days after study completion.
- •Subject is judged by the investigator to be suitable for participation in a 12 month clinical trial involving open-label dasotraline treatment.
- •Subject can read well enough to understand the informed consent form and other subject materials.
排除标准
- •Subject is considered by the investigator to be at imminent risk of suicide, injury to self or to others, or damage to property.
- •Subject is considered a suicide risk in the investigator's opinion or has any previous history of suicide attempt within the past 12 months.
- •Subject answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C SSRS assessment at OL Baseline. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
- •Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory tests that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
- •Subject has a positive urine drug screen (UDS) or breath alcohol test at OL Baseline.
- •Subject is breastfeeding.
- •Subject is at high risk of non-compliance in the investigator's opinion.
研究组 & 干预措施
Dasotraline
Experimental
4, 6, 8 mg flexibly dosed
干预措施: Dasotraline (Drug)
结局指标
主要结局
Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS)
时间窗: Baseline to Week 52
Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior
Frequency and Severity of Suicidal Behavior Using the C-SSRS
时间窗: Baseline to Week 52
Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior
次要结局
- Change in Body Weight(Baseline, Week 52)
- Percent Change in Body Weight (kg)(Baseline, Week 52)
- Change in Body Mass Index(Baseline, Week 52)
- Percent Change in Body Mass Index (kg/m^2)(Baseline, Week 52)
- Change in Fasting Lipid Panel, Triglyceride's(Baseline, Week 52)
- Change in Fasting Lipid Panel , Total Cholesterol(Baseline, Week 52)
- Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,(Baseline, Week 52)
- Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)(Baseline, Week 52)
- Change in Hemoglobin A1c Levels(Baseline, Week 52)
- Change in Fasting Glucose Levels(Baseline, Week 52)
- Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores(Baseline, Week 52)
- Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) Score(Baseline, Week 52)
- Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability)(Baseline, Week 52)
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score(Baseline, Week 52)
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Baseline, Week 52)
- Change in SF-12 Two Component Scores (Physical, Mental Health)(Baseline, Week 52)
研究者
研究点 (52)
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