Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity

Фаза 2/3 Прекращено NCT04815967

Заболевание	Spasticity, Cerebrovascular Accident, Multiple Sclerosis, Traumatic Brain Injury
Фаза	Фаза 2/3
Спонсор	Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
Статус	Прекращено
Участники	32 участн.
Вмешательство	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
Дата начала	2.11.2021
Дата завершения	23.04.2023
Публикация результатов	27.05.2026

Кратко

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
Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units)	2.82 ± 0.405 units on a scale
Phase 2 (DBP); Placebo	2.73 ± 0.467 units on a scale
Phase 2 (DBP); High Dose MYOBLOC (15,000 Units)	2.05 ± 0.762 units on a scale
Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units)	1.82 ± 0.681 units on a scale
Phase 2 (DBP); Placebo	2.65 ± 0.580 units on a scale

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
Phase 2 (DBP); Low Dose MYOBLOC (10,000 Units)	2.6 ± 0.67 score on a scale
Phase 2 (DBP); Placebo	3.3 ± 0.48 score on a scale

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