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NCT05059223 (AXS-12 in Narcolepsy): BVCT ex-ante prediction vs. reported outcome

On 1 Dec 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 25 Mar 2024 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
NCT05059223
Acronym
SYMPHONY
Drug Name
AXS-12 (reboxetine)
Drug MoA
selectively inhibitor of the reuptake of norepinephrine
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Narcolepsy
Human Patients
90
Sponsor
Axsome Therapeutics
Phase
Phase 3

Prediction of , index 896

Prospective Prediction
Prediction Index
896
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
115 days in advance
Readout Data Interpretation
83% cataplexy attack reduction achieved by AXS12; superior to 49-69% cataplexy attack reduction achieved by the SoC Sodium oxybate (doi.org/10.1016/j.sleep.2003.11.002) primary and secondary endpoints met.
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
A Randomized, Double-Blind, Placebo-Controlled, Multi- Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy
Phase
Phase 3
Status
Completed
Enrollment
90
Lead sponsor
Axsome Therapeutics, Inc.
Conditions
Narcolepsy; Cataplexy; Excessive Daytime Sleepiness
Interventions
DRUG: AXS-12 (reboxetine); DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2021-09-15
Primary completion
2024-03-15
Completion
2024-03-15
Primary outcomes
  • Frequency of cataplexy attacks (Change from Baseline to Week 5)

NCT05059223 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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