BioinvestGPT ApS · Research use only

NCT05122650 (JZP385 in Essential Tremor): BVCT ex-ante prediction vs. reported outcome

On 21 Nov 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 20 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

Drug Name
JZP385
Drug MoA
t-type calcium channel antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Essential Tremor
Human Patients
420
Sponsor
Jazz Pharmaceuticals
Phase
Phase 2

Prediction of , index 776

Prospective Prediction
Prediction Index
776
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
212 days in advance
Readout Data Interpretation
endpoints not met.
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
A Phase 2b, 12-week, Double-blind, Placebo-controlled, Randomized, Parallel Group, Multicenter Study of the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor
Phase
Phase 2
Status
Completed
Enrollment
420
Lead sponsor
Jazz Pharmaceuticals
Conditions
Essential Tremor
Interventions
DRUG: JZP385; OTHER: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2021-12-06
Primary completion
2024-05-30
Completion
2024-05-30
Results first posted
2025-07-24
Primary outcomes
  • Change From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and Placebo (Change from baseline to week 12)

NCT05122650 on ClinicalTrials.gov

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