Trial Tokenization and Linking to Real World Data: Extending the effectiveness and safety analysis of a new focal seizure treatment

Ashley L. O’Donoghue, PhD; Nayantara Biswas, MA; Tenzin Dechen, MPH, et al

Recently, a biopharmaceutical company completed at 36 week Phase IV study of 175 patients across 40 trial sites to evaluate the effectiveness and safety of a recently approved anti-seizure medication as adjunctive therapy in focal seizure. Patient retention was the primary efficacy endpoint and seizure frequency was a secondary efficacy endpoint. The study also looked at tolerability. The initial study results showed that a substantial number of patients remained on therapy and experienced reduced seizure frequency.