A Randomized, Placebo-controlled, Double-blind Phase 2 Study to Assess the Efficacy, Safety, Tolerability, and Pharmacodynamics of SPG302 in Adult Participants Diagnosed With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician
研究概览
简要总结
This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.
详细描述
This Phase 2 study will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia. This is a randomized, placebo-controlled study of SPG302 administered once daily for six weeks.
This study will entail weekly visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 18-65
- •Primary diagnosis of schizophrenia
- •Clinical laboratory values within normal range or < 1.5 times ULN
- •Currently prescribed only one antipsychotic medication, with stable dose for at least 4 weeks
- •Able and willing to provide written informed consent
排除标准
- •Any physical or psychological condition that prohibits study completion
- •Known cardiac disease
- •Active or history of malignancy in the past 5 years
- •History of clinically significant CNS event or diagnosis in the past 5 years.
- •Receipt of investigational products within 30 days
- •Blood donation within 30 days
研究组 & 干预措施
Active SPG302 to be administered to participants with Schizophrenia
Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.
干预措施: SPG302 (Drug)
Placebo comparator to be administered to participants with Schizophrenia
Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician
时间窗: 6 weeks
The PANSS is a scale to measure symptom severity of schizophrenia. Thirty symptoms of schizophrenia are evaluated by a clinician on a seven point sale, with 1 = absence of symptoms and 7 = extremely severe symptoms. This study will rate each score change by calculating the difference between baseline scale and completion of study intervention.
Electroencephalogram analysis to assess brain electrical activity
时间窗: 6 weeks
Electroencephalograms (EEG) will provide a non-invasive measurement of brain activity. This test will be used to measure specific brain responses to stimuli, including attention and decision making electrical activity and detection of unexpected changes in the auditory environment.
Change in smooth pursuit eye tracking from baseline
时间窗: 6 weeks
Participants will follow visual targets on a computer screen to assess for accuracy of following the item, and smoothness of eye movements. The visual target on the computer screen will follow several different tracking patterns and at various speeds.
次要结局
- Safety and tolerability of SPG302 in patients with schizophrenia(6 weeks)
- Change in Global Impressions Improvement scale as determined by clinician(6 weeks)
- Change in MATRICS Consensus Cognitive Battery scale as determined by clinician(6 weeks)
- World Health Organization Quality of Life - Abbreviated Assessment Questionnaire-brief version from baseline(6 weeks)
- Change in Personal and Social Performance from baseline(6 weeks)