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NCT04658186 (minzasolmin in Early-stage Parkinson's Disease): BVCT ex-ante prediction vs. reported outcome

On 26 Apr 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 16 Dec 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

NCTID
NCT04658186
Acronym
ORCHESTRA
Drug Name
minzasolmin (UCB0599)
Drug MoA
ASYN-misfolding inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Early-stage Parkinson's Disease
Human Patients
496
Sponsor
UCB Biopharma
Phase
Phase 2

Prediction of , index 1567

Prospective Prediction
Prediction Index
1567
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit with inferior-to-levodopa efficacy in MDS-UPDRS)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak clinical benefit in MDS-UPDRS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
234 days in advance
Readout Data Interpretation
minzasolmin failed to meet any primary and secondary efficacy endpoints
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 Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's Disease
Phase
Phase 2
Status
Completed
Enrollment
496
Lead sponsor
UCB Biopharma SRL
Conditions
Early-stage Parkinson's Disease
Interventions
DRUG: UCB0599; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-12-30
Primary completion
2024-09-06
Completion
2024-09-06
Results first posted
2025-10-31
Primary outcomes
  • Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Day 0 (Day 0)
  • Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 2 (Month 2)
  • Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 4 (Month 4)
  • Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 6 (Month 6)
  • Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 8 (Month 8)

NCT04658186 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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