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NCT05206513 (Valbenazine in Dyskinesia Cerebral Palsy): BVCT ex-ante prediction vs. reported outcome

On 30 Nov 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 22 Dec 2025 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05206513
Drug Name
Valbenazine
Drug MoA
VMAT2 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Dyskinesia Cerebral Palsy
Human Patients
86
Sponsor
Neurocrine Biosciences
Phase
Phase 3

Prediction of , index 1363

Prospective Prediction
Prediction Index
1363
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
753 days in advance
Readout Data Interpretation
valbenazine did not meet primary or key secondary endpoints; AEs consistent with established profile
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal modeling of the MoA in the exact clinical setting of dyskinetic cerebral palsy that has been permanently improved
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
Phase
Phase 3
Status
Completed
Enrollment
86
Lead sponsor
Neurocrine Biosciences
Conditions
Dyskinesia; Cerebral Palsy
Interventions
DRUG: Placebo; DRUG: Valbenazine
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-04-15
Primary completion
2025-10-16
Completion
2026-03-31
Primary outcomes
  • Change in the Total Maximal Chorea (TMC) Score of the Unified Huntington Disease Rating Scale (UHDRS) from Baseline to the Average of the Week 12 and Week 14 assessments (Baseline, Week 12 and Week 14)

NCT05206513 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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