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A Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label Extension

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Trial Profile

A Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label Extension

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 07 Aug 2026

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At a glance

  • Drugs Opakalim (Primary)
  • Indications Generalised epilepsy
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms SHINE
  • Sponsors Biohaven Therapeutics

Most Recent Events

  • 26 May 2026 According to Biohaven Therapeutics media release, as of 1H 2026, the double-blind study completion rates were 95%; and rollover rates in the optional open-label extension were 95%.
  • 26 May 2026 According to Biohaven Therapeutics media release, data from this trial will be presented at its annual R&D Day held in conjunction with the Yale Innovation Summit at the Yale School of Management in New Haven, Connecticut on May 27, 2026.
  • 26 May 2026 Results published in a Biohaven Therapeutics media release

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