A Single-Arm, Single-Site, Single-Dose Phase 1 Study Assessing the Safety of Bryostatin in the Treatment of Patients With Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Study Medication Discontinuation
研究概览
简要总结
This is a single-site, single-arm, single-dose, Phase 1 study of the safety of bryostatin in participants with multiple sclerosis (MS) receiving any disease modifying therapy (DMT).
详细描述
The study is 42 weeks in duration, including safety and exploratory outcomes evaluation at 30 days after the last full assessment (Week 28) and long-term follow-up at 12 weeks after the last full assessment (Week 40). Participants will receive a total of 14 doses over 26 weeks.
Eligible participants will be treated with bryostatin over a 26-week period. Doses 1, 2, 8, and 9 of the study drug will be a loading dose 20% higher (i.e., 24 µg) than the assigned fixed dose and will be administered one week apart. Otherwise, the assigned fixed dose is 20 µg. Drug is administered intravenously (IV) by continuous infusion over 45 (±5) minutes. Participants are scheduled to receive 14 doses over 26 weeks.
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
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bryostatin 1
Participants in this arm will receive treatment with Bryostatin 1
干预措施: Bryostatin 1 (Drug)
结局指标
主要结局
Study Medication Discontinuation
时间窗: Over 40 weeks
Frequency of study medication discontinuation and reason thereof
Adverse Events
时间窗: Over 40 weeks
Frequency of Adverse Events \[Treatment Emergent AEs (TEAEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARS)\]
CNS inflammatory effects
时间窗: Over 40 weeks
Potential CNS inflammatory effects as captured by clinical monitoring and MRI
次要结局
未报告次要终点
研究者
Robert Fox
Vice Chair for Research, Neurological Institute, Staff Neurologist, Cleveland Clinic Mellen Center for MS Treatment and Research
The Cleveland Clinic