A Study of TAK-861 in People With Narcolepsy Type 1
3期
已完成
NCT06505031
| 适应症 | Narcolepsy Type 1 |
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| 分期 | 3期 |
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| 申办方 | Takeda |
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| 状态 | 已完成 |
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| 受试者人数 | 105 人 |
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| 干预（药物） | TAK-861 |
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| 开始日期 | 2024年10月8日 |
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| 完成日期 | 2025年6月4日 |
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| 结果公布日 | 2026年7月16日 |
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摘要
The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms and daily life functions; and to learn about the safety of TAK-861.
Change From Baseline to Week 12 in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) Wake Trials
Baseline, Week 12 · minutes
| Placebo | -1.01 ± 1.529 minutes |
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| Oveporexton | 19.09 ± 1.254 minutes |
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| p-value | <0.001 |
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| LS Mean Difference | 20.09 (95% CI 16.57–23.61) |
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Change From Baseline to Week 12 in ESS Total Score
Baseline, Week 12 · score on a scale
| Placebo | -1.57 ± 0.676 score on a scale |
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| Oveporexton | -11.10 ± 0.550 score on a scale |
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| p-value | <0.001 |
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| Least Square (LS) Mean Difference | -9.53 (95% CI -11.10–-7.97) |
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