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

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
Praxis Precision Medicines
Study ID
NCT06087276
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 60 mg ulixacaltamide — DRUG
    Once daily oral treatment with titration
  • Placebo — DRUG
    Once daily oral treatment

Study Details

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.

Key Dates

Start date
Nov 2, 2023
Status verified
Sep 2025
Primary completion
Sep 30, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Parallel Design: ulixacaltamide arm
    Double-blind Part: Oral dosing, once daily in the morning with titration over 14 days to 60 mg ulixacaltamide: 7 days of 20 mg, 7 days of 40 mg, 70 days of 60 mg
  • Placebo Comparator: Parallel Design: placebo arm
    Double-blind Part: Oral dosing, once daily in the morning: 84 days of placebo
  • Experimental: Randomized Withdrawal
    Double-blind Part: Oral dosing, once daily in the morning with titration over 14 days to 60 mg ulixacaltamide: 7 days of 20 mg, 7 days of 40 mg, 42 days of 60 mg Randomized Withdrawal Part: Following double-blind part: 1:1 randomization to placebo or 60 mg ulixacaltamide for 28 days
  • Experimental: Long-term Safety Study: Essential1 rollovers
    Open-label Part: Oral dosing, once daily in the morning up to 3 years 60 mg ulixacaltamide
  • Experimental: Long-term Safety Study: Parallel Design and Randomized Withdrawal rollovers
    Open-label Part for patients previously on placebo: Oral dosing, once daily in the morning with titration over 14 days to 60 mg ulixacaltamide: 7 days of 20 mg, 7 days of 40 mg, up to 3 years 60 mg ulixacaltamide Open-label Part for patients previously on 60 mg ulixacaltamide: Oral dosing, once daily in the morning up to 3 years 60 mg ulixacaltamide
  • Experimental: Long-term Safety Study: Direct Enrollment to LTSS Study
    Oral dosing, once daily in the morning with titration over 14 days to 60 mg ulixacaltamide: 7 days of 20 mg, 7 days of 40 mg, up to 3 years 60 mg ulixacaltamide

Primary Outcome Measure

Parallel Design: Change from Baseline (CFB) to Week 8 (Day 56) on mADL11 score [ Time Frame: 8 weeks (56 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
United BioSource LLCMorgantownWest Virginia26508-

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By research site
United BioSource LLC· Morgantown, WV

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