A Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type a (YY001) for Injection in the Treatment of Upper Limb Spasticity in Adults (REHAB-1)

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a randomized, double-blind, dose escalation, placebo- and active-controlled parallel-group multi-center phase II study to evaluate the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) for injection in the treatment of upper limb spasticity in adults

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.

• Weight ≥ 50 kg.

• Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to randomized enrollment) exhibiting upper limb spasticity.

• Subjects with Disability Assessment Scale score of at least 2 on the Principal Target of Treatment (one of four functional domains: hygiene, dressing, limb position and pain).

• If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.

• If the study limb receives physical therapy or occupational therapy, the frequency, type, and intensity must be stable for at least 3 weeks prior to randomized enrollment.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
West China Hospital,Sichuan University
RECRUITING
Chengdu
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Sun Yat-sen Memorial Hospital
RECRUITING
Guangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
The Second People's Hospital of Hefei
RECRUITING
Hefei
The First Affiliated Hospital of Henan University
RECRUITING
Kaifeng
The Second Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Qilu Hospital of Shandong University
RECRUITING
Qingdao
Rui Jin Hospital of Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Shanghai Fudan University HuaShan Hospital
RECRUITING
Shanghai
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
RECRUITING
Shanghai
Shenzhen Second People's Hospital
RECRUITING
Shenzhen
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Shanxi provincial people's Hospital
RECRUITING
Taiyuan
Tianjin Medical University General Hospital
RECRUITING
Tianjin
RenMin Hospital Of Wuhan University
RECRUITING
Wuhan
Xuzhou Medical University Affiliated Hospital
RECRUITING
Xuzhou
Contact Information
Primary
Jieru Bai
bai.jieru@claruvis.com
+86 13883955310
Backup
Xiaoyun Sun, Ph.D
sun.xiaoyun@claruvis.com
+86 13810399273
Time Frame
Start Date: 2024-09-14
Estimated Completion Date: 2025-05-16
Participants
Target number of participants: 50
Treatments
Experimental: Treatment Group
Single injection with Recombinant Botulinum Toxin Type A for injection (YY001) in upper limb spasticity
Active_comparator: Active-Controlled Group
Single injection with BOTOX® in upper limb spasticity
Placebo_comparator: Placebo-Controlled Group
Single injection with placebo in upper limb spasticity
Related Therapeutic Areas
Sponsors
Leads: Chongqing Claruvis Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov