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NCT04201093 (tavapadon in early Parkinson's Disease): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 26 Sep 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially probably insufficient as monotherapy (combotherapy data TBD).

Clinical Trial

NCTID
NCT04201093
Acronym
TEMPO-1
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
early Parkinson's Disease
Human Patients
522
Sponsor
AbbVie
Phase
Phase 3

Prediction of , index 1455

Prospective Prediction
Prediction Index
1455
Prediction Date
Commercial Prediction
partial SUCCESS (commercially insufficient additive clinical benefit superior to levodopa for patients who receive tavapadon + MAOB inhibitor combotherapy); partial FAILURE (commercially insufficient clinical benefit non-superior to levodopa for patients who receive tavapadon monotherapy)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
225 days in advance
Readout Data Interpretation
tavapadon achieved -11.5 to -12 improvement (p< 0.0001) in MDS-UPDRS Parts II and III combined score at week 26; numerically slightly superior to -10.8 improvement in MDS-UPDRS total score achieved by Levodopa at week 26 (doi/full/10.1056/NEJMoa033447 ); thus commercially insufficient because levodopa is a generic.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably insufficient as monotherapy (combotherapy data TBD)
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, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)
Phase
Phase 3
Status
Completed
Enrollment
529
Lead sponsor
AbbVie
Conditions
Parkinson Disease
Interventions
DRUG: Tavapadon; DRUG: Placebo; DRUG: Tavapadon
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2019-12-13
Primary completion
2024-06-28
Completion
2024-06-28
Results first posted
2025-07-28
Primary outcomes
  • Change From Baseline in the MDS-UPDRS Parts II and III Combined Score (Week 26)

NCT04201093 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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