This is a phase Ib/II clinical study to evaluate the safety and efficacy of recombinant botulinum toxin type A(JHM03)in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo in adult patients with upper limb spasticity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Single treatment, intramuscularly injected. The total injection 100-150U.
Single treatment, intramuscularly injected. The total injection 200-250U.
Single treatment, intramuscularly injected. The total injection 350-400U.
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
The incidence rate of adverse events and severe adverse events
The incidence rate of adverse events and severe adverse events within 12 weeks after injection;
Time frame: Within 12 weeks
Change from baseline at week 4 for primary targeted muscle group on the MAS
Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale).
Time frame: Within 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Single treatment, intramuscularly injected. The total injection ≤400U.
Single treatment, intramuscularly injected.
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Huazhong University of Science and Technology Union Hospital
Shenzhen, Guangdong, China
The Second Hospital of Hebei Medical Hospital
Shijiazhuang, Hebei, China
Luoyang Central Hospital
Luoyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
...and 10 more locations