A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Ga ...
A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2) - ENDYMION 2 A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term ...
Participants with DS and LGS will receive: Participants weighing <45 kg: Soticlestat, mini-tablets, titrated from lower dose level (60mg to 140mg) to higher dose (100mg to 200mg) twice daily (BID), based on body weight, orally/via gastrostomy tube (G-tube) or percutaneous endoscopic gastrostomy (PEG) tube, up to 2 weeks in Titration Period. Will continue to receive dose that they are on at the end of Titration Period, for approximately 4 years in Maintenance Period. Dose will be tapered down to lower dose (not less than the lowest dose level based on weight) every 3 days until study drug is discontinued (up to 1 week) in Taper Period. Participants weighing >= 45kg or adults: Soticlestat mini-tablets or tablets with starting dose of 200 mg BID followed by 300 mg BID, up to 2 weeks in Titration Period. Will continue to receive 300 mg BID for approximately 4 years in Maintenance Period. Dose will be tapered down up to 100 mg every 3 days until study drug is discontinued (up to 1 week) in Taper Period. Participants with DS and LGS will receive: Participants weighing <45 kg: Soticlestat, mini-tablets, ...