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NCT06505031 (TAK861 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 14 Jul 2025 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
NCT06505031
Acronym
RadiantLight
Drug Name
TAK861
Drug MoA
OX2R agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Narcolepsy Type 1
Human Patients
105
Sponsor
Takeda
Phase
Phase 3

Prediction of , index 1910

Prospective Prediction
Prediction Index
1910
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in MWT for NT1 non-inferior non-superior to ORX750/ALKS2680 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
156 days in advance
Readout Data Interpretation
TAK861 met all primary and secondary endpoints
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 Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
Phase
Phase 3
Status
Completed
Enrollment
105
Lead sponsor
Takeda
Conditions
Narcolepsy Type 1
Interventions
DRUG: TAK-861; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2024-10-08
Primary completion
2025-06-04
Completion
2025-06-04
Results first posted
2026-07-16
Primary outcomes
  • Change From Baseline to Week 12 in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) Wake Trials (Baseline, Week 12)
  • Change From Baseline to Week 12 in ESS Total Score (Baseline, Week 12)

NCT06505031 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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