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NCT05550207 (AXS07 in Migraine): BVCT ex-ante prediction vs. reported outcome

On 6 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 24 Feb 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05550207
Acronym
EMERGE
Drug Name
AXS07 (meloxicam and rizatriptan)
Drug MoA
COX antagonist and 5HT1B/5HT1D agonist
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Migraine
Human Patients
100
Sponsor
Axsome Therapeutics
Phase
Phase 3

Prediction of , index 1663

Prospective Prediction
Prediction Index
1663
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit superior to meloxicam/rizatriptan monotherapy)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
202 days in advance
Readout Data Interpretation
AXS07 achieved >24-hour sustained pain relief for 31.2% more patients than after oral CGRPs (p<0.001) and statistically significant mTOQ4 total score superior to oral CGRP inhibitors (p<0.001)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
An Open-Label, Multiple-Dose Evaluation of the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor
Phase
Phase 3
Status
Completed
Enrollment
100
Lead sponsor
Axsome Therapeutics, Inc.
Conditions
Migraine
Interventions
DRUG: AXS-07 (meloxicam-rizatriptan)
Design
Single group · None
Primary purpose
Treatment
Start
2022-08-31
Primary completion
2024-11-27
Completion
2024-11-27
Primary outcomes
  • Percentage of subjects with headache pain relief (Hour 2 following dose administration)
  • Percentage of subjects with absence of the Most Bothersome Symptom (Hour 2 following dose administration)

NCT05550207 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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