Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET)

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2023
PRAX‐944‐321 is a decentralized, Phase 3, multi‐study, clinical trial evaluating the safety and efficacy of ulixacaltamide in essential tremor (ET). The study includes 2 separate and simultaneous phase 3 pivotal studies, of which one is a parallel design (PD) and the other a randomized withdrawal (RW), with all participants undergoing one screening process and a long‐term safety study (LTSS). This study also includes a separate LTSS study for eligible pivotal study and PRAX‐944‐222 open label extension (OLE) participants.
Epistemonikos ID: d574ce101be84be1e19d945b3027d487439d4f62
First added on: May 15, 2024