Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy

[...] ng to accepted values of the Body Mass Index Chart (18.0 to 3540 kg/m2). Is able to swallow capsules whole without crushing, [...] e freedom. Taking at least 1 ASM at Screening and Baseline. If following a diet plan along with the ASM, the participant should have been on a stable diet plan for at least 1 month prior to screening (Visit 1). The diet plan should be maintained throughout the duration of the study. Participants on a ketogenic diet will not be permitted to participate in the [...] At least 4 seizures accepted by the Epilepsy Study Consortiu [...] nfirm FCD/probable FCD diagnosis. Be in good general hea [...]

This is a multicenter, three-phase, long-term open-label study assessing the safety and tolerability of SPN-817 (huperzine A, an acetylcholinesterase inhibitor) in adults 18-70 years of age with treatment resistant epilepsy. The Screening period is up to 8 weeks in duration. For, followed by a Titration Period of 9 weeks and a Maintenance Period of 12 weeks (total Treatment Period of 21 weeks) for eligible participants,. The Treatment periodPeriod iswill 20 weeks in durationbe followed by an optional Open-Label Extension period which is up to 52 weeks in duration. Schedule A will enroll partic [...]

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