A Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) in Adult Patients With Upper Limb Spasticity
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a phase III clinical study to evaluate the efficacy and safety of recombinant botulinum toxin type A（Eveotox）in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of Eveotox compared with placebo in adult patients with upper limb spasticity.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
• 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
Locations
Other Locations
China
Beijing Tsinghua Changgung Hospital
NOT_YET_RECRUITING
Beijing
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Huai 'an Second People's Hospital
ACTIVE_NOT_RECRUITING
Huai'an
Luoyang Central Hospital
RECRUITING
Luoyang
Pingxiang People's Hospital
RECRUITING
Pingxiang
Huashan Hospital Fudan University
RECRUITING
Shanghai
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
RECRUITING
Shanghai
Shengjing Hospital affiliated to China Medical University
RECRUITING
Shenyang
The Second Hospital of Hebei Medical Hospital
RECRUITING
Shijiazhuang
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Yantai Mountain Hospital
RECRUITING
Yantai
The Second Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Danhua Lin
danhua.lin@jhm-biopharma.com
15811460241
Backup
Lei Wang
lei.wang@jhm-biopharma.com
Time Frame
Start Date:2025-12-11
Estimated Completion Date:2028-01
Participants
Target number of participants:207
Treatments
Active_comparator: Treatment Group
Eveotox will be administered in double-blind fashion at cycle 1 followed by up to 3 open-label cycles of Eveotox.
Placebo_comparator: Placebo-Controlled Group
Placebo will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 cycles of Eveotox.