144. レノックス・ガストー症候群 Lennox-Gastaut syndrome Clinical trials / Disease details


臨床試験数 : 111 薬物数 : 72 - (DrugBank : 14) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 61

  
1 trial found
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1JPRN-jRCT2051210182
04/03/202202/03/2022A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut SyndromeA 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 Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)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.
Nonomura HidenoriNULLRecruiting>= 2age old<= 36age oldBoth376Phase 3Australia;Belgium;Canada;China;Spain;France;United Kingdom;Greece;Hungary;Italy;Latvia;Netherlands;Poland;Serbia;Russia;Ukraine;USA;Japan