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NCT06087276 (Ulixacaltamide in Essential Tremor): BVCT ex-ante prediction vs. reported outcome

On 15 May 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 28 Feb 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT06087276
Acronym
Essential3
Drug Name
Ulixacaltamide
Drug MoA
T-type calcium channels blocker
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Essential Tremor
Human Patients
1000
Sponsor
Praxis Precision Medicines
Phase
Phase 3

Prediction of , index 1622

Prospective Prediction
Prediction Index
1622
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
289 days in advance
Readout Data Interpretation
ulixacaltamide discontinued further development due to insufficient efficacy at pre-define interim analysis
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
Phase 3, Decentralized, Randomized, Double-Blind, Placebo Controlled, Parallel Design, Randomized Withdrawal, and Long-term Safety Study to Evaluate the Efficacy and Safety of Ulixacaltamide (PRAX-944) in Adults With Essential Tremor
Phase
Phase 3
Status
Active not recruiting
Enrollment
1000
Lead sponsor
Praxis Precision Medicines
Conditions
Essential Tremor
Interventions
DRUG: 60 mg ulixacaltamide; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2023-11-02
Primary completion
2025-10-10
Completion
2028-07
Primary outcomes
  • Parallel Design: Change from Baseline (CFB) to Week 8 (Day 56) on mADL11 score (8 weeks (56 days))
  • Randomized Withdrawal: The proportion of participants that maintain response, as defined by change in mADL11 score, following randomized withdrawal (12 weeks (84 days))
  • Long-term Safety Study: Number of participants with Adverse Events (AE) and their severity. (Up to 3 years)

NCT06087276 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials