BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04223193 (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 9 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (as monotherapy).

Clinical Trial

NCTID
NCT04223193
Acronym
TEMPO-2
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
304
Sponsor
AbbVie
Phase
Phase 3

Prediction of , index 1456

Prospective Prediction
Prediction Index
1456
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient 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
299 days in advance
Readout Data Interpretation
tavapadon monotherapy achieved -9.1 improvement (p< 0.0001) in MDS-UPDRS Parts II and III combined score at week 26; non-superior to -10.2 improvement in MDS-UPDRS total score achieved by Levodopa at week 26 (no data announced for tavapadon + MAOA combotherapy)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (as monotherapy)
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 in Early Parkinson's Disease (TEMPO-2 Trial)
Phase
Phase 3
Status
Completed
Enrollment
304
Lead sponsor
AbbVie
Conditions
Parkinson Disease
Interventions
DRUG: Tavapadon; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2020-01-06
Primary completion
2024-10-01
Completion
2024-10-01
Results first posted
2025-11-21
Primary outcomes
  • Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score (Week 26)

NCT04223193 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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