Rare epilepsy study (Phase 1b/2a)
Soticlestat for adults with rare developmental and epileptic encephalopathies (DEE)
A randomized, double-blind, clinical study was designed to characterize the safety profile of soticlestat, measure 24HC plasma levels and determine changes in seizure frequency in adults with rare DEE
Status: This study has been completed. Further development and research of soticlestat will be led by our partner Takeda, including Phase 3 studies in children and adults with Dravet syndrome and Lennox-Gastaut syndrome scheduled to begin in 2021.
For more information about the Phase 1b/2a study of soticlestat in patients with RARE DEEs, please visit: Article about Phase 1b/2a Rare Epilepsy study »
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ENDYMION study (Open-Label Extension)
Soticlestat in rare epilepsies extension study
ENDYMION is a multi-center, open-label extension study of soticlestat in any patient who has participated in any previous soticlestat developmental and epileptic encephalopathy (DEE) clinical study, including patients with CDKL5 deficiency disorder, Dup15q syndrome, Dravet syndrome and Lennox-Gastaut syndrome. The primary objective of ENDYMION is to assess the long-term safety and tolerability of soticlestat in patients with DEEs and, secondarily, to evaluate the effect of soticlestat on seizure control over time.
Status: Ovid Therapeutics announced interim results from the ENDYMION study. For more information on these study results, please see the press release>>
Additional Information: This study is active and will continue under direction from our partner Takeda. For more information please visit the ENDYMION study page on clinicaltrials.gov>>. Further development and research of soticlestat will be led by our partner Takeda, including Phase 3 studies in children and adults with Dravet syndrome and Lennox-Gastaut syndrome scheduled to begin in 2021.
If you have questions, or are in need of additional information about Ovid’s clinical studies, please contact us>>