Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity
第2/3相
早期終了
NCT04815967
| 対象疾患 | Spasticity, Cerebrovascular Accident, Multiple Sclerosis, Traumatic Brain Injury |
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| 相 | 第2/3相 |
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| スポンサー | Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC |
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| ステータス | 早期終了 |
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| 参加者数 | 32 名 |
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| 介入（薬剤） | Phase 2; Low Dose MYOBLOC (10,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units), Phase 2; Placebo, Phase 3; MYOBLOC, Phase 3; Placebo |
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| 開始日 | 2021年11月2日 |
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| 完了日 | 2023年4月23日 |
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| 結果公開日 | 2026年5月27日 |
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概要
Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of upper limb spasticity in adults followed by an open-label extension safety trial.
The Change From Baseline in Modified Ashworth Scale (MAS) Score for Tone of the Primary Target Muscle Group (PTMG) Selected for Treatment at Week 4 Post-injection.
Baseline and Week 4 · units on a scale
| Phase 2 (DBP); High Dose MYOBLOC (15,000 Units) | 2.90 ± 0.568 units on a scale |
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| Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units) | 2.82 ± 0.405 units on a scale |
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| Phase 2 (DBP); Placebo | 2.73 ± 0.467 units on a scale |
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| Phase 2 (DBP); High Dose MYOBLOC (15,000 Units) | 2.05 ± 0.762 units on a scale |
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| Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units) | 1.82 ± 0.681 units on a scale |
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| Phase 2 (DBP); Placebo | 2.65 ± 0.580 units on a scale |
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The Clinical Global Impression of Change (CGI-C) Score in Functional Ability at Week 4 Post-injection.
Week 4 · score on a scale
| Phase 2 (DBP); High Dose MYOBLOC (15,000 Units) | 2.4 ± 0.70 score on a scale |
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| Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units) | 2.6 ± 0.67 score on a scale |
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| Phase 2 (DBP); Placebo | 3.3 ± 0.48 score on a scale |
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