CompletedPhase 2

SFX-01 After Subarachnoid Haemorrhage

United Kingdom90 participantsStarted 2016-04

Plain-language summary

This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria

Timeframe: up to 28 days

Maximum CSF Concentration [Cmax],

Timeframe: up to 28 days

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

Timeframe: up to 28 days

Trial details

NCT IDNCT02614742

SponsorEvgen Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09

View on ClinicalTrials.gov More Subarachnoid Hemorrhage, Spontaneous trials

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria

Timeframe: up to 28 days

Maximum CSF Concentration [Cmax],

Timeframe: up to 28 days

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

Timeframe: up to 28 days