A Study of Soticlestat in Adults and Children With Rare Epilepsies
2상
조기 종료
NCT03635073
| 대상 질환 | Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome |
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| 임상 단계 | 2상 |
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| 스폰서 | Takeda |
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| 상태 | 조기 종료 |
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| 참여자 수 | 156 명 |
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| 중재(약물) | Soticlestat |
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| 시작일 | 2018년 7월 19일 |
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| 완료일 | 2025년 7월 30일 |
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| 결과 공개일 | 2026년 3월 19일 |
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요약
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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BENITIONS에서 보기
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