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TAK-861 in Narcolepsy Type 1
NCT06505031Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2024
- Primary completion
- Jun 2025
- Countries
- 11
- Sponsor
- Takeda
- Modality
- Small Molecules
- Drugs
- oveporexton
- Conditions
- narcolepsy type 1 (NT1)
01
Overview
Phase 3, randomised, double-blind trial in narcolepsy type 1 (NT1) comparing Placebo with TAK-861 (2 arms). Primary endpoints: Mean Sleep Latency From the Maintenance of Wakefulness Test Wake Trials at 12 weeks and Epworth Sleepiness Scale Total Score at 12 weeks. Started Oct 2024; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Participants received oveporexton matching placebo tablets, orally, twice daily (BID) for 12 weeks.
TAK-861
Participants received oveporexton tablets, 2 mg, orally, BID for 12 weeks.
03
Who it enrols
Participants must have a confirmed diagnosis of Narcolepsy Type 1 with at least 4 cataplexy episodes per week, be positive for the HLA-DQB1*06:02 genotype or have low CSF orexin/hypocretin-1 levels, and have a BMI between 18 and 40 kg/m^2. Key exclusions include other medical disorders associated with excessive daytime sleepiness, significant cardiovascular, hepatic, or psychiatric conditions, recent cancer, and a history of epilepsy or head trauma.
04
Endpoints
Primary
Mean Sleep Latency From the Maintenance of Wakefulness Test Wake Trials
Epworth Sleepiness Scale Total Score
Secondary
Weekly Cataplexy Rate
Mean Number of Lapses on the Psychomotor Vigilance Test
Patient Global Impression of Change Score
Narcolepsy Severity Scale for Clinical Trials Total Score
Functional Impacts of Narcolepsy Instrument Domain Scores
Short Form-36 Survey Mental and Physical Component Scores
Number of Participants With At Least One Treatment-Emergent Adverse Event
05
Results
Primary endpoints met
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