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NCT06087276

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

Active, Not Recruiting
PHASE3Ages 18–85InterventionalTreatment
Praxis Precision Medicines
~1,000 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:60 mg ulixacaltamidePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parallel Design: Change from Baseline (CFB) to Week 8 (Day 56) on mADL11 score
Measured over 8 weeks (56 days)
+2 more outcomes measured

Conditions

Essential Tremor

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Where it's being run

1 sites across 1 states
West Virginia1

Study leadership

  • Director, Clinical Development · STUDY_DIRECTOR · Praxis Precision Medicines

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Participants with completely excised non-melanoma skin cancer (such as basal cell carcinoma or squamous cell carcinoma) or cervical carcinoma in situ are permitted at any time.
Participants with a history of other malignancies deemed cured by adequate treatment are also permitted at any time. 21. Has any other significant disease or disorder including but not limited to uncontrolled seizure or epilepsy, diabetes, cardiovascular disease, renal disease, laboratory abnormalities, or environmental factor that, in the opinion of the investigator or sponsor designee, may either put the participant at risk due to participation in the clinical trial, may influence or confound the result of the clinical trial, or may affect the participant's ability to participate in the clinical trial. Uncontrolled epilepsy or seizure is exclusionary and is defined as a seizure or epilepsy diagnosed by a medical clinician and a documented seizure or change in seizure medication (medication or dose) in the last 2 years. An estimated glomerular filtration rate (eGFR) of \<60 using the 2021 Chronic Kidney Disease-Epidemiology (CKD-EPI) formula mL/min/1.73m2 or urine albumin creatinine ratio (uACR) of ≥ 30 mg/g is exclusionary. 22. Participant has a positive alcohol or drug screening (including cannabis and cannabis-derived products). The participant can be enrolled in the study, if they are willing to stop use of cannabis or cannabis-related products after the Screening Visit and have a negative cannabidiol (CBD) screen result at Baseline (Day 1). A positive amphetamine, benzodiazepine or opioid drug screening result could be allowed if it is determined that the result is a false positive (for example caused by another medication), or if the result is due to a documented prescribed medication (for example: benzodiazepine or opioid) that in the opinion of the investigator or sponsor designee, is prescribed for a medical condition that aligns with standard of care, is not associated with substance abuse and the investigator's assessment determines that the medical condition and medication dose is stable and expected to remain stable throughout the trial. 23. History of or evidence of psychogenic tremor 24. Prior participation in an ulixacaltamide clinical trial at any time or other clinical trial evaluating a potential drug for ET in the past 6 months (with the exception of participants with documentation that they received placebo treatment only), with the exception of participants that are currently enrolled in and complete the EOT visit in PRAX-944-222 extension period.

What this trial measures

  • Parallel Design: Change from Baseline (CFB) to Week 8 (Day 56) on mADL11 score8 weeks (56 days)

    Modified Activities of Daily Living 11 (mADL11) is a composite sum of items 1 to 11 of the TETRAS-ADL subscale. The impact to each function is rated on a 5-point Likert scale from 0 to 4. Before calculating the total score, a scoring adjustment is applied to each item score. The modified score is calculated as the sum of all 11 items (with scoring adjustments) and ranges from 0 to 33 where larger values represent increased direct tremor impact to activities of daily living.

  • Randomized Withdrawal: The proportion of participants that maintain response, as defined by change in mADL11 score, following randomized withdrawal12 weeks (84 days)

    Modified Activities of Daily Living 11 (mADL11) is a composite sum of items 1 to 11 of the TETRAS-ADL subscale. The impact to each function is rated on a 5-point Likert scale from 0 to 4. Before calculating the total score, a scoring adjustment is applied to each item score. The modified score is calculated as the sum of all 11 items (with scoring adjustments) and ranges from 0 to 33 where larger values represent increased direct tremor impact to activities of daily living. Change in patient response will compare the proportion of patients in the ulixacaltamide and placebo arm who maintain response based on RW baseline established at Week 8 (Day 56) following randomized withdrawal.

  • Long-term Safety Study: Number of participants with Adverse Events (AE) and their severity.Up to 3 years

    The number of participants with Adverse Events (AE) will be reported by preferred term