BENITIONSClinical Trial Intelligence

Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects

3期 已完成 NCT01994109

适应症Sialorrhea
分期3期
申办方Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
状态已完成
受试者人数187 人
干预(药物)MYOBLOC
开始日期2013年11月
完成日期2016年1月
结果公布日2019年8月15日

摘要

This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected directly into the salivary glands. MYOBLOC has been shown in previous trials to safely decrease saliva production, thereby demonstrating its potential as a safe and effective treatment for troublesome sialorrhea.

Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)

4 Weeks · g/minute

MYOBLOC 2500 U-0.37 ± 0.03 g/minute
MYOBLOC 3500 U-0.36 ± 0.03 g/minute
Placebo-0.07 ± 0.03 g/minute
p-value<0.0001

Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)

4 weeks · score on a scale

MYOBLOC 2500 U2.38 ± 0.12 score on a scale
MYOBLOC 3500 U2.45 ± 0.12 score on a scale
Placebo3.59 ± 0.13 score on a scale
p-value<0.0001

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。