A Study of Soticlestat in Adults and Children With Rare Epilepsies
2期
提前终止
NCT03635073
| 适应症 | Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome |
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| 分期 | 2期 |
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| 申办方 | Takeda |
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| 状态 | 提前终止 |
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| 受试者人数 | 156 人 |
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| 干预(药物) | Soticlestat |
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| 开始日期 | 2018年7月19日 |
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| 完成日期 | 2025年7月30日 |
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| 结果公布日 | 2026年3月19日 |
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摘要
The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment. Participants will receive soticlestat twice a day. Participants will visit the study clinic every 2-6 months throughout the study. Study treatments may continue as long as the participant is receiving benefit from it.
Percentage of Participants Who Experienced At Least One Treatment-emergent Adverse Event (AE)
From screening up to end of the study (up to approximately 84 months) · percentage of participants
| Soticlestat | 91.0 percentage of participants |
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Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS)
Baseline, Week 338 · score on a scale
| Soticlestat | 32.3 ± 21.64 score on a scale |
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| Soticlestat | 0.7 ± 0.58 score on a scale |
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| Soticlestat | 33.5 ± 29.19 score on a scale |
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| Soticlestat | -3.0 ± 2.83 score on a scale |
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| Soticlestat | 12.3 ± 15.89 score on a scale |
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| Soticlestat | -5.5 ± 2.12 score on a scale |
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Change From Baseline in Behavior Measures Using Total Scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for Participants Greater Than Equal to (≥) 6 Years of Age
Baseline, Week 338 · score on a scale
| Soticlestat | 36.8 ± 26.11 score on a scale |
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| Soticlestat | -16.3 ± 8.50 score on a scale |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。