A Study of TAK-861 in People With Narcolepsy Type 1
第3相
完了
NCT06505031
| 対象疾患 | Narcolepsy Type 1 |
|---|
| 相 | 第3相 |
|---|
| スポンサー | Takeda |
|---|
| ステータス | 完了 |
|---|
| 参加者数 | 105 名 |
|---|
| 介入（薬剤） | TAK-861 |
|---|
| 開始日 | 2024年10月8日 |
|---|
| 完了日 | 2025年6月4日 |
|---|
| 結果公開日 | 2026年7月16日 |
|---|
概要
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 |
|---|
| Oveporexton | 19.09 ± 1.254 minutes |
|---|
| p-value | <0.001 |
|---|
| LS Mean Difference | 20.09 (95% CI 16.57–23.61) |
|---|
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 |
|---|
| Oveporexton | -11.10 ± 0.550 score on a scale |
|---|
| p-value | <0.001 |
|---|
| Least Square (LS) Mean Difference | -9.53 (95% CI -11.10–-7.97) |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。