A Clinical Study to Evaluate the Safety and Efficacy of JHM03 in Adult Patients With Upper Limb Spasticity
NCT ID: NCT06584240
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
84 participants
INTERVENTIONAL
2024-09-14
2025-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental Group 1
Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles
Sequence 1
Single treatment, intramuscularly injected. The total injection 100-150U.
Experimental Group 2
Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles
Sequence 2
Single treatment, intramuscularly injected. The total injection 200-250U.
Experimental Group 3
Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles
Sequence 3
Single treatment, intramuscularly injected. The total injection 350-400U.
Experimental Group 4
Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles
Sequence 4
Single treatment, intramuscularly injected. The total injection ≤400U.
Placebo Group
Participants will receive one cycle of Placebo in the selected overactive upper limb muscles
Sequence 5
Single treatment, intramuscularly injected.
Interventions
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Sequence 1
Single treatment, intramuscularly injected. The total injection 100-150U.
Sequence 2
Single treatment, intramuscularly injected. The total injection 200-250U.
Sequence 3
Single treatment, intramuscularly injected. The total injection 350-400U.
Sequence 4
Single treatment, intramuscularly injected. The total injection ≤400U.
Sequence 5
Single treatment, intramuscularly injected.
Eligibility Criteria
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Inclusion Criteria
* Body weight ≥50Kg
* Participants with stable post-stroke Spasticity (ULS) for at least 3 months
* Participants with Modified Ashworth Scale (MAS) score of at least 2 at elbow flexor or wrist flexor or finger flexor
* Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain)
* Participants who have been stable for at least 1 month prior to study entry in terms of oral antispasticity
Exclusion Criteria
* History of alcohol or drug abuse.
* Known allergy or hypersensitivity to any component of the study products.
* History of epilepsy
* Known or suspected to be HIV positive, serologically positive for syphilis, or active hepatitis B or C
* Any medical condition that may put the participant at increased risk for botulinum toxin type A use
18 Years
80 Years
ALL
No
Sponsors
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JHM BioPharma (Tonghua) Co. , Ltd.
NETWORK
Responsible Party
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Locations
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Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
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
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, China
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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JHM03-CT102
Identifier Type: -
Identifier Source: org_study_id
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