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NCT04542499 (Tavapadon in Parkinson's Disease): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 18 Apr 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: overall statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04542499
Acronym
TEMPO-3
Drug Name
Tavapadon
Drug MoA
a selective D1R/D5R partial agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Parkinson's Disease
Human Patients
507
Sponsor
AbbVie / Cerevel Therapeutics
Phase
Phase 3

Prediction of , index 1454

Prospective Prediction
Prediction Index
1454
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
64 days in advance
Readout Data Interpretation
on time 1.7 hours vs 0.6 hours (p<0.0001); key registrational endpoint MDS-UPDRS not met; key registrational endpoint off time reduction met yet fail to reach the minimally clinically meaningful threshold (-1.0 hour and -3.5 points [10.1002/mds.23638.]).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
overall 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 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial)
Phase
Phase 3
Status
Completed
Enrollment
507
Lead sponsor
AbbVie
Conditions
Parkinson Disease
Interventions
DRUG: Tavapadon; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2020-09-23
Primary completion
2024-01-29
Completion
2024-02-15
Results first posted
2025-03-25
Primary outcomes
  • Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) (Week 26)

NCT04542499 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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