Status:
COMPLETED
A Clinical Study to Evaluate the Safety and Efficacy of JHM03 in Adult Patients With Upper Limb Spasticity
Lead Sponsor:
JHM BioPharma (Tonghua) Co. , Ltd.
Conditions:
Upper Limb Spasticity
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 obse...
Eligibility Criteria
Inclusion
- Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
- 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
- Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study.
- 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
Key Trial Info
Start Date :
September 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06584240
Start Date
September 14 2024
End Date
July 23 2025
Last Update
September 2 2025
Active Locations (20)
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1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
2
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
3
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
4
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China