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NCT06358950 (Alixorexton in Narcolepsy Type 1): BVCT ex-ante prediction vs. reported outcome

On 8 Feb 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 7 Sep 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (no approved treatment so far).

Clinical Trial

NCTID
NCT06358950
Acronym
Vibrance-1
Drug Name
Alixorexton (ALKS 2680)
Drug MoA
OX2R agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Narcolepsy Type 1
Human Patients
92
Sponsor
Alkermes
Phase
Phase 2

Prediction of , index 1908

Prospective Prediction
Prediction Index
1908
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in MWT for NT1 non-inferior non-superior to ORX750/TAK861 in the best-case scenarios of optimal dosing regimens)
Technical Prediction
SUCCESS (statistically significant clinical benefit in MWT for NT1 compared with placebo featuring a positive dose-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
211 days in advance
Readout Data Interpretation
Alixorexton met the primary endpoint in MSL on MWT at week 6 (24 min for 4mg with p=0.01; 26 minutes for 6mg with p<0.0001; 28 minutes for 8mg with p<0.0001) and the key secondary endpoint in ESS (-6.4 for 4mg with p=0.01; -8.7 for 6mg with p<0.0001; -8.3 for 8mg with p<0.0001)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant 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 1
Phase
Phase 2
Status
Completed
Enrollment
92
Lead sponsor
Alkermes, Inc.
Conditions
Narcolepsy Type 1
Interventions
DRUG: ALKS 2680; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-03-24
Primary completion
2025-06-19
Completion
2025-07-31
Primary outcomes
  • Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6 (Baseline to Week 6)

NCT06358950 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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