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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group 1 | Experimental | Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles |
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| Experimental Group 2 | Experimental | Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles |
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| Experimental Group 3 | Experimental | Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles |
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| Experimental Group 4 | Experimental | Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles |
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| Placebo Group | Placebo Comparator | Participants will receive one cycle of Placebo in the selected overactive upper limb muscles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequence 1 | Drug | Single treatment, intramuscularly injected. The total injection 100-150U. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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; | 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). | Within 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Beijing | Beijing Municipality | China | |||
| The First Hospital of Lanzhou University |
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JHM03 and Placebo
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Double-blinded
| Sequence 2 | Drug | Single treatment, intramuscularly injected. The total injection 200-250U. |
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| Sequence 3 | Drug | Single treatment, intramuscularly injected. The total injection 350-400U. |
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| Sequence 4 | Drug | Single treatment, intramuscularly injected. The total injection ≤400U. |
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| Sequence 5 | Drug | Single treatment, intramuscularly injected. |
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| 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 |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Huai 'an Second People's Hospital | Huai'an | Jiangsu | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
| Pingxiang People's Hospital | Pingxiang | Jiangxi | China |
| Shengjing Hospital affiliated to China Medical University | Shenyang | Liaoning | China |
| Rizhao People's Hospital | Rizhao | Shandong | China |
| Yantai Mountain Hospital | Yantai | Shandong | China |
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Yangzhi Affiliated Rehabilitation Hospital of Tongji University | Shanghai | Shanghai Municipality | China |