Focal Epilepsy
The MRTLE2 study evaluates the safety and effectiveness of a new method to treat medically refractory epilepsy referred to as Intracerebroventricular (ICV) drug delivery. A new formulation of the anti-epileptic drug sodium valproate is delivered directly into the fluid spaces of the brain using a catheter connected to a drug infusion pump implanted under the skin in the participant’s abdomen.
Participants will be assigned, at random, to receive ICV administration of the study drug or placebo. Following completion of the trial, participants will have the option to enrol in an open-label extension study in which all participants receive the study drug.
What you need to know
Who can take part?
- Participants between 18 and 75 years old with confirmed refractory focal epilepsy for a minimum of 2 years
- People who have not achieved seizure control from at least 3 anti-epileptic drugs
- People who have 6 or more seizures per month
- People who are suitable for surgical implantation of the drug delivery device
- People who do not currently take valproate
What is involved for you?
Participants will be implanted with an intracerebral catheter attached to a reservoir for delivery of the study drug directly into the brain. A drug infusion pump is surgically implanted under the skin in the abdomen and connected to the intracerebral catheter via a connecting line that is located under the skin.
Participants will undergo the following procedures and tests:
- Physical exam and vital signs
- Neurological exams
- Neurosurgical exams
- Device implantation surgery
- X-rays and CT scans
- Electrocardiograms
- EEG recording
- MRI scan
- Questionnaires
- Blood tests
- Urine tests
- Sampling of cerebrospinal fluid via the implanted device
- Refill of drug into the implanted pump
- Keeping a seizure diary
Trial dates
This trial is accepting participants until August 2023.