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TAK-861 in Narcolepsy Type 1
NCT05687903Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2023
- Primary completion
- Dec 2023
- Countries
- 12
- Sponsor
- Takeda
- Modality
- Small Molecules
- Drugs
- oveporexton
- Conditions
- narcolepsy type 1 (NT1)
01
Overview
Phase 2, randomised, double-blind trial of oveporexton in narcolepsy type 1 (NT1) (5 arms), sponsored by Takeda. Primary endpoint: Average Sleep Latency as Determined From the Maintenance of Wakefulness Test at Week 8. Started Jan 2023; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo BID
TAK-861 0.5 mg BID
0.5 mg BID
TAK-861 2 mg BID
2 mg BID
TAK-861 2/5 mg BID
2 mg followed by 5 mg BID
TAK-861 7 mg QD
7 mg QD
03
Endpoints
Primary
Average Sleep Latency as Determined From the Maintenance of Wakefulness Test
Secondary
Epworth Sleepiness Scale Total Score
Weekly Cataplexy Rate
Treatment-emergent Adverse Events
04
Results
Primary endpoints met
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