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NCT05668754 (serdexmethylphenidate in Idiopathic Hypersomnia): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 26 Mar 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient to advance to phase 3.

Clinical Trial

NCTID
NCT05668754
Drug Name
serdexmethylphenidate (SDX)
Drug MoA
norepinephrine/dopamine reuptake inhibitors
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Idiopathic Hypersomnia
Human Patients
50
Sponsor
Zevra Therapeutics
Phase
Phase 2

Prediction of , index 1056

Prospective Prediction
Prediction Index
1056
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
41 days in advance
Readout Data Interpretation
primary safety endpoint met and secondary efficacy endpoints meaningful.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient to advance to phase 3
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 2, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study to Determine the Safety and Efficacy of Oral SDX in Patients With Idiopathic Hypersomnia (IH)
Phase
Phase 2
Status
Completed
Enrollment
66
Lead sponsor
Zevra Therapeutics
Conditions
Idiopathic Hypersomnia
Interventions
DRUG: Serdexmethylphenidate; OTHER: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-12-28
Primary completion
2024-02-28
Completion
2024-03-21
Results first posted
2026-06-30
Primary outcomes
  • Change From Baseline in Epworth Sleepiness Scale (ESS) Score (Start to end of DBWP (2 weeks))

NCT05668754 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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