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NCT05972044 (Solriamfetol in attention deficit hyperactivity disorder): BVCT ex-ante prediction vs. reported outcome

On 5 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 25 Mar 2025 readout could not be adjudicated and sits outside the scored cohort.

Clinical Trial

NCTID
NCT05972044
Acronym
FOCUS
Drug Name
Solriamfetol
Drug MoA
norepinephrine-dopamine reuptake inhibitor and TAAR1 agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
attention deficit hyperactivity disorder (ADHD)
Human Patients
516
Sponsor
Axsome Therapeutics
Phase
Phase 3

Prediction of , index 1210

Prospective Prediction
Prediction Index
1210
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
414 days in advance
Readout Data Interpretation
solriamfetol achieved a statistically significant 3.3 point placebo-adjusted AISRS total score improvement at week 6 (p=0.039); which is non-superior to viloxazine’s 3.8 point placebo-adjusted AISRS total score improvement at week 6 (p=0.004)(see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Unadjudicatable Prediction
Clinical Benefit Conclusion
statistically significant and commercially maybe sufficient; unadjudicatable prediction because the official MoA of solriamfetol as a TAAR1 agonist is likely to be misinformation that shall be adjudicated with the readouts of both ENGAGE study and the SUSTAIN study compared with our updated ex-ante predictions No. 1900 and No. 1902 in which solriamfetol was modelled without TAAR1 agonism
Prediction Classification
—

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults With ADHD.
Phase
Phase 3
Status
Completed
Enrollment
516
Lead sponsor
Axsome Therapeutics, Inc.
Conditions
ADHD
Interventions
DRUG: Solriamfetol 150 mg; DRUG: Solriamfetol 300 mg; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2023-07-06
Primary completion
2025-02-07
Completion
2025-03-14
Primary outcomes
  • Change from Baseline to Week 6 in the AISRS total score (6 weeks)

NCT05972044 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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