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NCT05028569 (BOTOX in Episodic Migraine): BVCT ex-ante prediction vs. reported outcome

On 9 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 24 Nov 2025 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
NCT05028569
Drug Name
BOTOX
Drug MoA
botulinum toxin type A
Drug Modality
protein biologic
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Episodic Migraine
Human Patients
775
Sponsor
AbbVie
Phase
Phase 3

Prediction of , index 1738

Prospective Prediction
Prediction Index
1738
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in reducing monthly episodic migraine days)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak clinical benefit in reducing monthly episodic migraine days)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
472 days in advance
Readout Data Interpretation
BOTOX failed to meet the primary endpoint of monthly migraine days compared with placebo (P>0.7)
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
Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX (Botulinum Toxin Type A) for the Prevention of Migraine in Subjects With Episodic Migraine
Phase
Phase 3
Status
Terminated
Enrollment
775
Lead sponsor
AbbVie
Conditions
Episodic Migraine
Interventions
DRUG: BOTOX; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Prevention
Start
2021-11-05
Primary completion
2024-11-06
Completion
2024-11-06
Results first posted
2025-12-09
Primary outcomes
  • Change From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6 (Baseline, Months 5-6)
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) (Double-Blind Phase (Week 0-24); Open-Label Phase (Week 24-48))

NCT05028569 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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