Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity
2/3상
조기 종료
NCT04815967
| 대상 질환 | Spasticity, Cerebrovascular Accident, Multiple Sclerosis, Traumatic Brain Injury |
|---|
| 임상 단계 | 2/3상 |
|---|
| 스폰서 | Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC |
|---|
| 상태 | 조기 종료 |
|---|
| 참여자 수 | 32 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 |
|---|
| 시작일 | 2021년 11월 2일 |
|---|
| 완료일 | 2023년 4월 23일 |
|---|
| 결과 공개일 | 2026년 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); 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 |
|---|
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.