An Open-label Extension of SPG302-ALS-001 Study to Evaluate the Long-term Safety and Efficacy of Daily Oral SPG302 Treatment in Participants With Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Treatment emergent adverse events and serious adverse events
研究概览
简要总结
This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALS-101 with Amyotrophic Lateral Sclerosis (ALS)
详细描述
This is an open-label extension study of SPG302-ALS-001 to investigate the long-term safety, tolerability, and efficacy of SPG302 administered orally in participants with Amyotrophic Lateral Sclerosis (ALS). This study will allow participants in the parent study to continue dosing. Enrolled participants will continue at the dose they received at the end of the first trial, and will self-administer SPG302 orally every day for up to 52 weeks. Participants will have an in-person clinic visit every 3 months (± 3 days) and a monthly phone visit. An end of treatment visit will occur within 7 days of the last dose of SPG302. A final visit to collect safety data will be conducted up to 1 month (± 3 days) post last dose.
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
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have participated in all study activities of SPG302-ALS-001, the parent study
排除标准
- •Unable to reliably and regularly swallow whole oral medications on a daily basis.
- •Medical conditions that investigator or sponsor determine would interfere with participation in clinical trial
研究组 & 干预措施
Experimental: Open Label Extension
Active SPG302 to be administered to adult participants with ALS who completed initial study. Dose to be administered to be dose received during previous study.
干预措施: SPG302 (Drug)
结局指标
主要结局
Treatment emergent adverse events and serious adverse events
时间窗: Up to 52 weeks
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
C-SSRS (Columbia Suicide Severity Rating Scale)
时间窗: Up to 52 weeks
Prospective suicidality assessment is performed using the Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire to evaluate suicidal ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section is considered positive. The suicidal behavior lethality sub-scale evaluates the level of actual or potential medical damage
次要结局
- Changes from baseline in neurofilament light biomarker (NfL)(up to 52 weeks.)
- Change in the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) scores(up to 52 weeks)
- Change in Edinburgh Cognitive and Behavioural ALS Screen (ECAS)(up to 52 weeks)