Praxis Precision Medicines
The goal of this clinical study is to compare ulixacaltamide and placebo treatment in essential tremor. The main question it aims to answer is: • Is ulixacaltamide a safe and efficacious treatment for patients with essential tremor? Participants will be asked to participate in one of two clinical studies where they will be treated with either ulixacaltamide or placebo for a period of up to 12 weeks. After the controlled study completion, they will be eligible to participate in a long-term, open-label safety study (LTSS) and be treated with ulixacaltamide. Participants are eligible to enroll directly into the LTSS if they previously participated in an essential tremor trial, received sponsor invitation after being deemed ineligible for the controlled study, or following enrollment closure of the controlled study.
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 3 separate and simultaneous phase 3 pivotal studies where all participants undergo one screening process. The first study is a parallel design (PD) enrolling approximately 400 patients, the second is a randomized withdrawal (RW) enrolling approximately 200 patients and the last is a long-term safety study (LTSS) comprising up to 1000 patients. A total of 4 key efficacy hypotheses are being tested prospectively in the study. The…
Inclusion Criteria for Study 1 PD and Study 2 RW: 1. Has a body mass index (BMI) at Screening of ≥18 kg/m2. 2. Has a clinical diagnosis of ET confirmed during screening and characterized by postural and action tremor. 3. If currently receiving medication prescribed for ET, must be on ≤1 medications, on stable dose(s) for at least 1 month prior to Screening, and willing to maintain stable dose(s) throughout the study. As needed (PRN) use of prescribed ET medicines is not allowed with the exception of propranolol PRN. Participants prescribed propranolol PRN are eligible but must discontinue the…
Once daily oral treatment with titration
Once daily oral treatment
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