SFX-01 After Subarachnoid Haemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Maximum CSF Concentration [Cmax],
研究概览
简要总结
This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.
详细描述
The study is a randomised, double-blind, parallel-group design comparing SFX-01 (300 mg) taken orally as capsules or as a suspension via a nasogastric tube (NG) twice-daily for up to 28 days versus placebo in 90 patients who have had SAH and present within 48 hours of ictus.
Subjects will receive SFX-01/Placebo in order to review potential outcomes investigating the long-term complications of SAH such as Delayed Cerebral Ischaemia, as reflected by Trans-Cranial Doppler (TCD) readings. The objective is to demonstrate safety and search for signals of efficacy in patients that have had SAH.
A sub-study will be conducted in up to 12 patients where an External Ventricular Drain (EVD) fitted; serial CSF samples will be taken pre- & post-dose on two occasions to determine pharmacokinetics of Sulforaphane in CSF in comparison with plasma pharmacokinetics. Sub-study patients will undergo all other procedures (with the exception of lumbar puncture).
Treatment duration is up to 28 days; follow up duration is 28 days, three and six months. The planned trial period is 24 months.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with radiological evidence of spontaneous SAH
- •Fisher grade 3 or 4 on CT
- •Definitive treatment of aneurysm has not been ruled out
- •Previously living independently
- •In the opinion of the investigator, the delay from ictus to randomisation and initiation of trial medication will not exceed 48 hours
- •Aged 18 to 80 years
- •In the opinion of the investigator it will be possible to obtain Informed Consent from the Patient, Personal Legal Representative or Professional Legal representative within 24 hours of first dose
排除标准
- •Traumatic SAH
- •Fisher grade 1 or 2
- •SAH diagnosed on lumbar puncture with no evidence of blood on CT
- •Decision not to treat aneurysm has been made
- •Plan to withdraw treatment
- •Significant kidney disease as defined as plasma creatinine ≥2.5mg/dL (221 µmol/l)
- •Liver disease as defined as total bilirubin ≥2-fold the upper limit of normal; (ULN) as measured by the local laboratory
- •Females who are pregnant or lactating.
- •Participants enrolled in another interventional research trial in the last 30 days
- •Patients for whom it is known, at the time of screening, that clinical follow-up will not be feasible Patients unwilling to use two forms of contraception (one of which being a barrier method) 30 days for men and 90 days for women after last IMP dose
研究组 & 干预措施
SFX-01
300mg bid for up to 28 days.
干预措施: SFX-01 (Drug)
Placebo
300mg placebo bid for up to 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum CSF Concentration [Cmax],
时间窗: up to 28 days
To detect the presence of SFN in Cerebrospinal Fluid (CSF)
Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria
时间窗: up to 28 days
To evaluate the safety of up to 28 days of SFX-01 dosed at up to 96 mg Sulforaphane (SFN) per day
Number of participants with treatment related reduction in middle cerebral artery (MCA) peak flow velocity following Subarachnoid Haemorrhage (SAH) measured by trans cranial doppler ultrasound
时间窗: up to 28 days
To determine if a minimum of 7 days treatment with SFX-01 reduces Middle Cerebral Artery (MCA) peak flow velocity following Subarachnoid Haemorrhage (SAH).
次要结局
- Delayed Cerebral Ischaemia(Up to 28 days)
- modified Rankin Scale(up to 180 days post ictus)
- CSF drug levels(up to 14 days)
- Serum Haptoglobin levels(Up to 28 days)
- Plasma PK(up to 28 days)