A Randomized, Double-Blind, Active-Controlled,Phase 2/3 Study to Determine the Short-Term (6-Week) and Long-Term (6 Month) Cognitive and Anti-Psychotic Efficacy, Safety and Tolerability of CYP-1020 Compared to Risperidone in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 269
- 试验地点
- 39
- 主要终点
- Cognition
研究概览
简要总结
This is a randomized, double-blind, active-controlled, 6 month study designed to evaluate the cognitive effects of treatment with CYP-1020 compared to risperidone. The primary efficacy endpoint will occur after 6 weeks of treatment; additional (secondary) efficacy endpoints will occur after 12 and 24 weeks of treatment.
Up to 450 patients will be randomized to CYP-1020 or risperidone in a 1:1 ratio. The study will utilize a flexible dose escalation scheme designed to allow patients to titrate to their maximally tolerated dose; doses of CYP-1020 may range from a minimum of 15 mg to a maximum of 35 mg, whereas doses of risperidone will range from a minimum of 1 mg to 3 mg BID (2-6 mg daily). To ensure effective blinding across all treatment groups, all patients will be treated twice daily with study drug and/or placebo, as indicated (i.e., double-dummy design).
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant or lactating female, 18-50 years of age inclusive
- •Patients must have exhibited symptoms meeting the criteria of schizophrenia for at least one year, but not more than 20 years, prior to Screening
- •Recent onset (not more than 30 days) of worsening of psychiatric symptoms at Screening.
- •Currently experiencing an acute exacerbation of schizophrenia, as defined by the following results at Screening and Baseline:
- •≥70 total score on the PANSS
- •≥4 (moderate) on two of the following four PANSS items: (1) delusions, (2) hallucinatory behaviors, (3) conceptual disorganization or (4) suspiciousness/persecution, where at least one of the two items must be either delusions or hallucinatory behaviors
- •CGI-S score between 4 and 6 (moderately ill to severely ill) at the Screening and Baseline visits.
- •Has exhibited a sufficient clinical response to at least one previous course of an anti-psychotic agent prescribed at a generally recognized therapeutic dose.
- •Must have completed at least 5 years of formal education or its equivalent
排除标准
- •Breastfeeding or pregnant
- •Symptoms of schizophrenia for more than 20 years at the time of screening.
- •Psychotic symptoms that have failed to improve (based on Investigator's opinion or documented medical history) following sufficient treatment with therapeutic doses of two or more anti-psychotics agents over the preceding 2 years
- •Prior history of neuroleptic malignant syndrome
- •Prior history or current evidence of moderate or severe tardive dyskinesia (mild is acceptable).
- •Abnormal ECG evaluation
- •History of confirmed epilepsy or prior seizure disorder (history of a single febrile seizure is not exclusionary)
- •In the opinion of the investigator, unstable medical disease (e.g., malignancy, poorly controlled diabetes or hypertension, ischemic cardiac disease, dilated cardiomyopathy or valvular heart disease, pulmonary disease, liver disease, kidney disease)
- •Acute infectious disease (e.g., malaria, dengue fever, hepatitis A), or chronic infectious disease (e.g., history of AIDS or HIV positivity, tuberculosis)
- •Likely allergy, sensitivity or intolerance to BL-1020, perphenazine, risperidone, paliperidone, or any of the drug product excipients
- •Any suicide attempt within the preceding 2 years
- •Any Substance Dependence disorder
- •High likelihood of substance abuse
- •Diagnosis with one of the following DSM-IV-TR Axis I diagnoses: schizophreniform disorder, schizoaffective disorder, bipolar disorder, substance dependency, mood disorder with psychotic features; psychotic disorder NOS
- •Requiring chronic treatment with benzodiazepines
- •Requiring chronic treatment with mood stabilizers
- •Previously treated with clozapine within 6 months prior to screening
- •Any abnormal clinical laboratory test result that is judged by the Investigator to be clinically significant
- •History of, or serologic evidence of, acute or chronic active hepatitis B or C
研究组 & 干预措施
CYP-1020
Dose titration 15-35mg/day for 6 months
干预措施: CYP-1020 (Drug)
Risperidone
Dose titration 2-6mg/day for 6 months
干预措施: Risperidone (Drug)
结局指标
主要结局
Cognition
时间窗: Baseline and 6 weeks
To evaluate the cognitive benefits of treatment with CYP-1020 (formerly known as BL-1020) compared to risperidone after 6 weeks of treatment in patients experiencing acute exacerbation of schizophrenia. Assessed by calculating difference between CYP-1020 and Risperidone on mean change from baseline to Week 6 endpoint on MATRICS Consensus Cognition Battery (MCCB) normative composite score. MCCB is a neuropsychological test battery that comprises 10 measures of 7 different cognitive areas including speed of processing, verbal learning, memory-verbal and non verbal reasoning and problem solving, visual learning, social cognition, attention/vigilance.The study was terminated after the interim analysis. MCBB total score ranges from -50 to 150. Change from Baseline by Visit (LOCF)Higher score means better cognitive functioning.
次要结局
- Long Term Schizophrenia Treatment(Baseline and 6, 12 and 24 weeks of treatment)
- Long Term Cognition(12 and 24 weeks of treatment)