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NCT05642442 (Suvecaltamide in Moderate to Severe Residual Tremor in…): BVCT ex-ante prediction vs. reported outcome

On 21 Nov 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 6 Nov 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

Drug Name
Suvecaltamide
Drug MoA
t-type calcium channel antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Moderate to Severe Residual Tremor in Parkinson's Disease
Human Patients
169
Sponsor
Jazz Pharmaceuticals
Phase
Phase 2

Prediction of , index 1138

Prospective Prediction
Prediction Index
1138
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
716 days in advance
Readout Data Interpretation
suvecaltamide failed to meet the primary efficacy endpoint of TETRAS composite outcome score compared with placebo (P=0.2363)
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 17-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Flexible-dosing, Parallel-group, Multicenter Study of the Efficacy and Safety of Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants With Parkinson's Disease
Phase
Phase 2
Status
Completed
Enrollment
169
Lead sponsor
Jazz Pharmaceuticals
Conditions
Parkinson Disease; Tremor
Interventions
DRUG: Placebo; DRUG: Suvecaltamide
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-12-01
Primary completion
2024-10-23
Completion
2024-11-11
Results first posted
2026-01-15
Primary outcomes
  • Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score (Baseline to Week 17)

NCT05642442 on ClinicalTrials.gov

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