NCT01714713已完成3 期
A Multicenter 26-Week Extension Study to Evaluate the Safety and Clinical Effects of Prolonged Exposure to Two Doses of EVP-6124, an Alpha-7 Nicotinic Acetylcholine Receptor Agonist, as an Adjunctive Pro-cognitive Treatment in Subjects With Schizophrenia on Chronic Stable Atypical Antipsychotic Therapy
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
- 830
- 主要终点
- Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia
研究概览
简要总结
This study is being conducted to further investigate the safety of prolonged exposure to EVP-6124 in subjects with Schizophrenia receiving a stable dose of an atypical antipsychotic who completed double-blind treatment on studies EVP-6124-015 and EVP-6124-016.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the Day 182 visit in a previous 26-week double-blind study (EVP-6124-015 or EVP-6124-016).
- •Subject has signed informed consent for this extension study, indicating that the subject understands the purpose of and procedures required for the study, before the initiation of any extension study specific procedures. Subjects who are unable to provide informed consent will not be included in the study
- •No clinically significant changes in the subject's medical status during the participation in EVP-6124-015 or EVP-6124-
- •Any significant changes in health care status and their impact on subject eligibility will be reviewed by the investigator and sponsor on a case-by-case basis.
- •In the opinion of the investigator, the extension treatment is in the best interest of the subject.
- •Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Females and the female partners of male must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1 year, willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least one barrier method]). Female subjects must have a negative urine pregnancy test predose on Day 1.
排除标准
- •Significant risk for suicidal or violent behavior, as determined by the investigator. Significant risk for suicidal behavior is defined as 1) suicidal ideation as endorsed on items 4 and 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS); 2) suicidal behaviors detected by the C-SSRS; or 3) psychiatric interview and examination.
- •Adverse events from the previous study (EVP-6124-015 or EVP-6124-016) that have not resolved, are of moderate or greater severity and judged to be possibly related or related to study drug and are thought by the investigator to be contraindications to study participation.
- •Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
- •Female subjects who are pregnant.
- •Subjects who received any other investigational treatment during participation in either EVP-6124-015 or EVP-6124-016 other than assigned study medication.
研究组 & 干预措施
EVP-6124 low dose
Experimental
low dose Tablet, Once Daily, Day 1 through Day 182
干预措施: EVP-6124 (Drug)
EVP-6124, high dose
Experimental
high dose Tablet, Once Daily, Day 1 through Day 182
干预措施: EVP-6124 (Drug)
结局指标
主要结局
Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia
时间窗: Baseline through Day 182 or Early Termination
All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood/chemistry/urinalysis)
次要结局
- Change from Baseline in the Clinical Global Impression (CGI) - Severity (CGI-S) to Day 182(Baseline to Day 182 or Early Termination)
- Change from Baseline in the Clinical Global Impression (CGI) - Change (CGI-C) to Day 182(Baseline to Day 182 or Early Termination)
- Change from Baseline in the EuroQol-5D (EQ-5D-5L) to Day 182(Baseline to Day 182 or Early Termination)
- Change from Baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) to Day 182(Baseline to Day 182 or Early Termination)
- Change from Baseline in the Client Socio-Demographic and Service Receipt Inventory-European Version (CSSRI-EU) to Day 182(Baseline to Day 182 or Early Termination)
研究者
相似试验
已完成
不适用
Long-term Safety and Efficacy of Adipose-derived Stem Cells to Treat Complex Perianal Fistulas in Patients Participating in the FATT-1 Randomized Controlled TrialComplex Perianal FistulaNCT01020825Tigenix S.A.U.148
已完成
不适用
Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic PatientsPresbyopiaNCT03811249Refocus Group, Inc.287
终止
3 期
Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)Sleep Initiation and Maintenance DisordersMental DisordersDyssomniasSleep DisordersSleep Disorders, IntrinsicNCT00750919Merck Sharp & Dohme LLC184
终止
3 期
Study of the Safety and Clinical Effects of 2 Doses of EVP-6124 in Subjects With Alzheimer's Disease Who Complete Study EVP-6124-024 or EVP-6124-025DementiaAlzheimer's DiseaseNCT02004392FORUM Pharmaceuticals Inc348
已完成
2 期
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)Alagille SyndromeNCT02047318Mirum Pharmaceuticals, Inc.19