RAISE A clinical trial of a ganaxalone in status epilepticus

Status epilepticus involves prolonged, severe epileptic seizures. Patients who do not respond to available anti-epileptic drugs are at high risk of suffering brain damage or dying.
This study is assessing the safety and effectiveness of a new anti-epileptic drug, called ganaxalone in patients admitted to the Intensive Care Unit with status epilepticus that has failed to respond to two other anti-epileptic medications.

Category
Medical
Trial status
Active, not recruiting
Trial phase
Phase 3 Drug Trial
Late stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
Registry listing
NCT04391569
ERM Project ID
91307

Trial contact details

Contact person
Research Coordinator, Acute Care
Email
Acute.research@mater.org.au

What you need to know

Who can take part?

As patients who are eligible for this study are unable to provide their own consent, due to ongoing epileptic seizures, consent to participate will be obtained via a legally authorized representative (termed a Person Responsible in Queensland), such as a parent, guardian or next of kin.
To be eligible to participate in the study, a patient must meet the following criteria:
•   Person Responsible is available to provide informed consent
•   People aged 12 years or older
•   Suffering from status epilepticus which has failed to respond to two anti-epileptic drugs
•   Certain health and medical conditions and prior medications may prevent participation, as confirmed by the study doctor

What is involved for you?

Participants in the study will undertake the following treatments, procedures, tests and assessments:
•   Physical exam and medical history
•   Electroencephalogram (EEG)
•   Electrocardiogram (ECG)
•   Health questionnaires, completed at follow-up after recovery from seizures
•   Intravenous infusion of ganaxalone over 36 hours while hospitalised in Intensive Care
•   Blood tests
•   Urine tests

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