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NCT06555783 (Alixorexton in Narcolepsy Type 2): BVCT ex-ante prediction vs. reported outcome

On 8 Feb 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 12 Nov 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (featuring a mild positive dose-response relationship) and commercially sufficient (no approved treatment so far).

Clinical Trial

NCTID
NCT06555783
Acronym
Vibrance-2
Drug Name
Alixorexton (ALKS2680)
Drug MoA
OX2R agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Narcolepsy Type 2
Human Patients
80
Sponsor
Alkermes
Phase
Phase 2

Prediction of , index 1909

Prospective Prediction
Prediction Index
1909
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in MWT for NT2; non-inferior non-superior to ALKS2680/TAK861 in the best-case scenarios of optimal dosing regimens)
Technical Prediction
SUCCESS (statistically significant clinical benefit in MWT for NT2 compared with placebo featuring a mild positive dose-response relationship and a moderate positive dose-toxicity relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
277 days in advance
Readout Data Interpretation
Alixorexton 14mg/18mg met the primary endpoint in MSL on MWT at week 8 (p<0.05) and Alixorexton 18mg met the key secondary endpoint in ESS (p<0.05)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (featuring a mild positive dose-response relationship) and commercially sufficient (no approved treatment so far)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 2
Phase
Phase 2
Status
Completed
Enrollment
93
Lead sponsor
Alkermes, Inc.
Conditions
Narcolepsy Type 2
Interventions
DRUG: ALKS 2680; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-07-26
Primary completion
2025-11-11
Completion
2025-11-21
Primary outcomes
  • Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT) (Baseline to Week 8)
  • Change in Epworth Sleepiness Scale (ESS) (Baseline to week 8)

NCT06555783 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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