The trial is enrolling adult epilepsy patients with temporal lobe onset, with or without secondary generalized seizures.
A clinical feasibility study at St. Vincent’s Hospital Melbourne (published in The Lancet – EClinicalMedicine) established for the first time that intracerebroventricular administration of sodium valproate is a potentially effective strategy in the treatment of refractory epilepsy. The study found that subjects experienced a mean 77 percent seizure reduction and extended periods of seizure freedom. All subjects reported significant quality of life improvement with minimal drug side effects. Based on these promising initial results, Cerebral Therapeutics has developed a propriety formulation, CT-010, and enhanced the infusion system for continued investigation of the safety and effectiveness of the therapy.
“The launch of this important Phase 2b study allows us to further pursue direct brain administration of an anti-epileptic drug that has the potential to dramatically reduce seizures and positively impact the lives of patients with refractory epilepsy,” said Dr. Mark Cook, Professor of Medicine at the University of Melbourne.
“Two out of three people diagnosed with epilepsy still cannot obtain control of seizures with currently available treatments,” said Dr. Jacqueline French, Epilepsy Foundation Chief Medical & Innovation Officer and Professor of Neurology at NYU Langone Health. “We still have a critical need for new and novel therapies to be explored for treatment resistant epilepsy. Results of the 2a are promising, and we look forward to the results of this next trial.”
Dan Abrams, MD, CEO of Cerebral Therapeutics noted that “The company’s brain targeted drug delivery approach combines the best of pharmaceutical and medical device technology to enable CT-010 to reach the site of action in the brain where it can help address refractory epilepsy while minimizing systemic drug exposure and side effects. We are pleased to advance this important new therapy with the initiation of this randomized clinical trial at leading epilepsy centers in Australia. The study will be expanded in 2021 at additional sites in Israel and the United States.”
Source: Company Press Release