A Clinical Study to Evaluate the Safety and Efficacy of JHM03 in Adult Patients With Upper Limb Spasticity

Launched by JHM BIOPHARMA (TONGHUA) CO. , LTD. · Sep 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment, called JHM03, to help adults with upper limb spasticity, a condition that causes stiffness and tightness in the muscles of the arms. The goal is to see if JHM03 is safe and effective compared to a placebo (a treatment that has no active medical effect) in reducing muscle tightness and improving daily activities like dressing and hygiene. The trial is currently recruiting participants aged 18 to 80 who have had stable upper limb spasticity for at least three months and meet certain criteria regarding their muscle stiffness and ability to perform daily tasks.

Eligible participants will need to weigh at least 50 kilograms and have not used any botulinum toxin treatments in the last six months. Throughout the study, participants will receive either JHM03 or a placebo, and they can expect regular check-ins to monitor their safety and progress. It’s important to note that individuals with certain medical conditions, such as a history of drug abuse or specific infections, will not be able to participate. This study aims to provide valuable information about a potential new treatment option for those struggling with upper limb spasticity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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