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

StatusActive, Not Recruiting
PhasePhase 3
Started2023-11-02
View on ClinicalTrials.gov ↗

Amendment history

2026-07-14
Enrolling by Invitation→Active, Not Recruiting Study Status v4
Trial statusEnrolling by Invitation→Active, Not Recruiting
Primary completion dateestimated 2025-09→confirmed 2025-10-10
Completion date2026-12→2028-07
2025-09-24
Recruiting→Enrolling by Invitation Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Trial statusRecruiting→Enrolling by Invitation
Primary completion date2024-09→2025-09
Completion date2025-04→2026-12
Enrollment target600→1000
Study arms5→6
Eligibility criteria+3,279 characters
Inclusion Criteria for Study 1 PD and Study 2 RW: Has a body mass index (BMI) at Screening of ≥18 kg/m2. Has [...] onfirm key inclusion criteria at Baseline Exclusion Criteria for Study 1 PD and Study 2 RW: Neuropathy, muscle weakness, arthropathy or other musculos [...] and complete the EOT visit in PRAX-944-222 extension period. Inclusion Criteria for Direct Enrollment into Study 3 LTSS (Following Closure of Enrollment for Study 1 PD and Study 2 RW) Has a clinical diagnosis of ET confirmed during screening and characterized by postural and action tremor. Women of childbearing potential must undertake preg [...]
Secondary endpoints18 to 6 entries
Parallel Design: The proportionRate of participantsDisease responding to ulixacaltamide,improvement as definedMeasured by change in mADL11 score after 12 weeks (84 days) of treatment Parallel Design: TETRAS-ADL Change from Baseline to Week 12 (Day 84) Parallel Design: PGI-C Change from Baseline toat Week 128 (Day 8456) Parallel Design: CGI-S Change from Baseline to Week 128 (Day 84) Parallel Design: PGI-S Change from Baseline to Week 12 (Day 84) Parallel Design: Proportion of participants responding to ulixacaltamide, as defined by change in mADL11 score after 14, 28, 56, and 70 days of treatm [...] [...]
Primary endpoints3 entries, revised
Parallel Design: Change from Baseline (CFB) to Week 128 (Day 8456) on mADL11 score
Study description+844 characters
[...] ulixacaltamide in essential tremor (ET). The study includes 23 separate and simultaneous phase 3 pivotal studies, ofwhere whichall participants undergo one screening process. The first study is a parallel design (PD) andenrolling approximately 400 patients, the othersecond is a randomized withdrawal (RW), withenrolling allapproximately participants200 undergoing one screening processpatients and the last is a long-term safety study (LTSS) comprising up to 1000 patients. ThisA total of 4 key efficacy hypotheses are being tested prospectively in the study. The analysis will be conducted simultan [...] [...]
Study sitesdetails revised at 1 of 1 site
2024-04-03
Study Status, Study Design, Outcome Measures, Eligibility v2
Enrollment target620→600
Eligibility criteria+4,235 characters
Inclusion Criteria: Has a body mass index (BMI) at Screening betweenof ≥18 and 40 kg/m2, inclusive. Has a clinical diagnosis of ET priorconfirmed toduring screening asand characterized by postural and action tremor. If currently receiving medication prescribed for ET, must b [...] s 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 PRN dose after the first day of screening. Primidone use is not allowed within 2 weeks prior to screeni [...] with a documented negative serum pregnancy t [...]
Primary endpoints3 entries, revised
Long-term Safety Study: Number of participants with Adverse Events (AE) and their severity. Parallel Design: Change from Baseline (CFB) to Week 12 (Day 84) on mADL11
2023-11-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11→confirmed 2023-11-02
Study sites0→1
2023-10-12
Original filing
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.
Trial Details
NCT Number NCT06087276
Lead Sponsor Praxis Precision Medicines
Conditions Essential Tremor
Enrollment 1,000 participants
Start Date 2023-11-02
Primary Completion 2025-10-10 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-16