BENITIONSClinical Trial Intelligence

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

2/3상 조기 종료 NCT04815967

대상 질환Spasticity, Cerebrovascular Accident, Multiple Sclerosis, Traumatic Brain Injury
임상 단계2/3상
스폰서Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
상태조기 종료
참여자 수32 명
중재(약물)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
시작일2021년 11월 2일
완료일2023년 4월 23일
결과 공개일2026년 5월 27일

요약

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); Placebo2.73 ± 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); Placebo2.65 ± 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); Placebo3.3 ± 0.48 score on a scale

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

같은 질환의 다른 임상

전체 임상

이 페이지는 ClinicalTrials.gov의 공개 데이터를 정리한 것입니다. 의학적 조언이 아니며 투자 권유나 자문도 아닙니다. 반드시 전문의와 상담하세요.