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 |
|---|
Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)
4 weeks · score on a scale
| MYOBLOC 2500 U | 2.38 ± 0.12 score on a scale |
|---|
| MYOBLOC 3500 U | 2.45 ± 0.12 score on a scale |
|---|
| Placebo | 3.59 ± 0.13 score on a scale |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
同一适应症的其他试验
全部试验
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。