RAISE II
Research type
Research Study
Full title
A double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety, and tolerability of intravenous ganaxolone added to standard of care in refractory status epilepticus.
IRAS ID
1007137
Contact name
Erin Abdallah
Contact email
Sponsor organisation
Marinus Pharmaceutical, Inc
Eudract number
2022-502540-12
Clinicaltrials.gov Identifier
Research summary
Status epilepticus (SE) is a state in which patients have many seizures/lose consciousness. Patients who fail 2 lines of treatment are referred to as Refractory SE (RSE). RSE is a medical emergency with no approved therapies for this condition.
Ganaxolone is an investigational drug, intended for the treatment of RSE. The Raise II study is a clinical study designed to compare the effect of ganaxolone or placebo added to standard therapy for RSE.
If the diagnosed RSE patient is eligible, in addition to standard therapies they will be randomly assigned to receive either ganaxolone or placebo. The patient will receive the study drug through intravenous infusion (IV). This will take 2 days. If needed, the doctor will adjust the dose or stop the infusion early.
After the study drug is stopped, the patient will have approximately 5 more days of tests. These daily tests will stop if the patient can leave the hospital earlier. The patient will then be in contact with the study team once a week for 4 weeks. The patient will be asked to return to the hospital at least 1 time, usually coinciding with a regular study doctor follow-up after hospitalization. The study will last for 4 weeks.If someone is thought to be at risk for RSE, they may be invited to take part in the study in case an RSE event occurs. This is called pre-consenting & is valid for 1 year.
The study team may ask a Legally Acceptable Representative (LAR) of a patient who currently has RSE to consent to have them take part in the study. The study team will ask them because the patient is not able to provide consent themselves. Once the patient is recovered enough, they will be asked to consent for continued participation in the study.
If no consent from the patient or a LAR is in place on time prior to start treatment, the doctor may enrol the patient into the study without prior consent of the patient & LAR. The study team will do every effort to obtain consent of the LAR or patient ASAP
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
23/LO/0590
Date of REC Opinion
14 Dec 2023
REC opinion
Further Information Favourable Opinion