Study of Radiprodil in patients with TSC or FCD Type II

• Research type

  Research Study

• Full title

  A Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms of Radiprodil in Patients with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) Type II

• IRAS ID

  1009849

• Contact name

  Michael Panzara

• Contact email

  michael.panzara@neurvati.com

• Sponsor organisation

  GRIN Therapeutics, Inc.

• Eudract number

  2023-506301-20

• Clinicaltrials.gov Identifier

  NCT06392009

• Research summary

  This is an open-label, multicenter, phase 1B/2A study in participants with TSC or FCD Type II. The study will consist of 2 parts; a dose escalation/maintenance period (Part A) to determine the safety, tolerability, and PK of multiple individually titrated doses of radiprodil, and a long-term follow-up period (Part B) to assess the treatment effect on seizures and behavioral symptoms. A safe and well tolerated dose after approximately 16 weeks of continuous treatment during Part A will be established, and initial signs of efficacy and changes in quality of life will be evaluated. The study will further evaluate the long-term safety and tolerability of radiprodil and assess the maintenance of the treatment effect during Part B.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  24/EE/0095

• Date of REC Opinion

  3 Jun 2024

• REC opinion

  Further Information Favourable Opinion