A Study of Soticlestat in Adults and Children With Rare Epilepsies
第2相
早期終了
NCT03635073
| 対象疾患 | Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome |
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| 相 | 第2相 |
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| スポンサー | Takeda |
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| ステータス | 早期終了 |
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| 参加者数 | 156 名 |
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| 介入(薬剤) | Soticlestat |
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| 開始日 | 2018年7月19日 |
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| 完了日 | 2025年7月30日 |
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| 結果公開日 | 2026年3月19日 |
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概要
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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BENITIONS で見る
ClinicalTrials.gov の原文を見る
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