By: IPP Bureau
Last updated : June 10, 2022 9:35 am
Marinus has broadened inclusion criteria in the RAISE trial to allow for enrollment of patients previously treated with IV anesthesia.
Marinus Pharmaceuticals, a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, announced that it has amended the protocol for its Phase 3 RAISE trial in refractory status epilepticus (RSE) to expand eligibility criteria, support patient recruitment and drive enrollment efficiencies at clinical sites.
“Based on extensive consultation with trial investigators and our Scientific Advisory Board, we are implementing protocol changes to the RAISE trial that we are confident will allow clinical sites to enroll a broader population of patients to support recruitment,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus. “We believe the updated protocol also brings improved convenience and clarity and meets the evolving needs of a hospital-based clinical trial.”
Marinus has broadened inclusion criteria in the RAISE trial to allow for enrollment of patients previously treated with IV anesthesia, as well as patients transferred from other hospitals or treated in the emergency room.
Marinus reached alignment with the U.S. Food and Drug Administration on the protocol amendment, including a proposal for a potential interim analysis. If the company chooses to do the interim analysis, it could potentially allow an early stop to the trial for efficacy data if the analysis were to meet the predefined statistical criteria.
To further support recruitment and enrollment, Marinus expects to initiate site activations in Canada in the third quarter of 2022 targeting 10 new sites and is evaluating further expansion into Israel and Australia. The company is targeting 65-75 sites globally and continues to expect topline data in the second half of 2023.
Ganaxolone development for RSE is being funded in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.