Current Phase 2b Clinical Trial

The MRTLE2 Study is a Phase IIb study evaluating the safety and efficacy of CT-010, a proprietary and investigational valproate solution, delivered to intraventricularly (ICV) via an implanted pump and specialized ICV port and delivery catheter.

The study will enroll up to 70 subjects to achieve 52 evaluable subjects with sites currently enrolling in Australia and Israel. The study is expected to expand to the United States in 2021.

The study is a blinded study that includes a baseline period evaluating seizure frequency of six weeks, a blinded Primary Evaluation Period of 84 days, and an option to roll over into an Open Label Long-Term Follow-Up Study. Subjects that were randomized to placebo will receive active drug during the Open-Label Long-Term Follow-up Period. Refer as well to study flow diagram below.

You can find additional information on the study here.

Study Flow Diagram