BHV-7000 in Subjects with Idiopathic Generalized Epilepsy with GTC seizures - SHINE

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1012092

• Contact name

  Michelle DeGrosky

• Contact email

  clinicaltrials@biohavenpharma.com

• Sponsor organisation

  Biohaven Therapeutics, Ltd. c/o Biohaven Pharmaceuticals Inc. (BPI)

• Clinicaltrials.gov Identifier

  NCT06425159

• Research summary

  Epilepsy is a neurological disease characterized by unexpected seizures. About one-third of people with epilepsy have idiopathic generalized epilepsy (IGE) with generalized tonic-clonic (GTC) seizures. These seizures occur in both the right and left sides of the brain together. Several antiseizure drugs are currently available, but they do not always ensure good control of seizures and can cause many side effects. Developing successful treatment for IGE is important to improve quality of life, and even to prevent death related to GTC seizures.
  The investigational drug BHV-7000 is a small molecule that works by increasing the opening of a channel protein called Kv7.2/7.3. The Kv7.2/7.3 channel is present on the surface of brain cells and regulates the brain’s electrical activity. By increasing its opening, BHV-7000 is thought to prevent seizures. BHV-7000 is also believed to be safer and better tolerated compared to other antiseizure drugs due to its unique structure. This study aims to evaluate if BHV-7000 is safe and effective for reducing GTC seizures in adults with IGE.
  Screening Period: between 20 and 42 days, during which participants continue to receive their current antiseizure treatment plan.
  Double-blind Treatment Period: up to 24 weeks of treatment with BHV-7000 or placebo, once a day, in addition to their current antiseizure treatment plan.
  Open-label Extension Period (optional): about 1 year of treatment with extended-release BHV-7000, in a dose up to 75 mg, once a day.
  Phase 2/3 study, with a planned enrollment of approximately 405 participants (adults aged 18 - 75 years) with IGE.
  Treatment groups:
  Group 1: 75 mg of BHV-7000 taken once a day for up to 24 weeks
  Group 2: placebo taken once a day for up to 24 weeks

• REC name

  Wales REC 1

• REC reference

  25/WA/0218

• Date of REC Opinion

  8 Sep 2025

• REC opinion

  Further Information Favourable Opinion