Evaluating JHM03 for treating upper limb spasticity in adults
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
This study is testing if a new treatment called JHM03 can help adults with upper limb spasticity improve their muscle control and daily functioning.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | JHM BioPharma (Tonghua) Co. , Ltd. Research network |
| Locations | 2 sites (Shanghai, Shanghai and 1 other locations) |
| Trial ID | NCT06584240 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the safety and efficacy of JHM03, a recombinant botulinum toxin type A, in adult patients suffering from upper limb spasticity. Participants will be randomly assigned to receive either JHM03 or a placebo, with the primary focus on measuring improvements in muscle tone and functional abilities. The study will include adults aged 18 to 80 who have stable post-stroke spasticity for at least three months and meet specific clinical criteria. The outcomes will be evaluated using standardized scales to determine the effectiveness of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with stable upper limb spasticity following a stroke.
Not a fit: Patients who have used botulinum toxin within the last six months or have certain medical conditions like epilepsy or active hepatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve muscle control and quality of life for patients with upper limb spasticity.
How similar studies have performed: Previous studies involving botulinum toxin for spasticity have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai and 1 other locations
- Shanghai Fudan University HuaShan Hospital — Shanghai, Shanghai, China (Recruiting)
- Huashan Hospital , Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Danhua Lin
- Email: danhua.lin@jhm-biopharma.com
- Phone: 15811460241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.