Axsome Therapeutics Reveals AXS-12 Meets Primary Endpoint In ENCORE Long-Term Phase 3 Trial In Narcolepsy
Axsome Therapeutics Reveals AXS-12 Meets Primary Endpoint In ENCORE Long-Term Phase 3 Trial In Narcolepsy
axsome therapeutics公司透露AXS-12在困擾性睡病的ENCORE長期3期試驗中達到主要終點
- AXS-12 statistically significantly reduced the frequency of cataplexy attacks compared to placebo (p=0.017, primary endpoint)
- Statistically significant improvement in cognition compared to placebo (p=0.011, NSAQ)
- Statistically significant improvement in narcolepsy overall compared to placebo (p=0.024, PGI-C)
- Cataplexy response (≥50% improvement) achieved by 72% of patients at 1 month and 82% at 6 months
- Improvement in excessive daytime sleepiness (EDS), assessed by the CGI-C, achieved by 84% of patients at 1 month and 78% at 6 months
- Improvement in narcolepsy overall, assessed by the CGI-C, achieved by 90% of patients at 1 month and 90% at 6 months
- Well-tolerated with long-term safety profile consistent with previously completed trials and no new safety signals detected
- NEW YORK, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Axsome The
- AXS-12在統計上顯著減少了與安慰劑相比的癲癇發作頻率（p=0.017，主要終點）
- 與安慰劑相比，認知功能有統計學顯著改善（p=0.011，NSAQ）
- 與安慰劑相比，嗜睡症總體情況有統計學顯著改善（p=0.024，PGI-C）
- 72%的患者在1個月時達到癲癇反應（≥50%改善），6個月時爲82%
- 84%的患者在1個月時實現過度白天嗜睡（EDS）的改善，6個月時爲78%，通過CGI-C進行評估
- 在嗜睡症總體狀況改善方面，90%的患者在1個月和6個月時都取得了通過CGI-C的評估改善
- 耐受性好，長期安全性特徵與以前完成的試驗一致，沒有檢測到新的安全信號
- 紐約，2024年11月26日（全球新聞網）-- Axsome The
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