Clinical trial NCT06783114: A Phase II Study on Recombinant Botulinum Toxin Type a (YY001) for Injection in the Treatment of Upper Limb Spasticity in Adults
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Upper Limb Spasticity
Keywords: YY001
Recombinant Botulinum Toxin Type A
Botulinum Toxin
Upper limb spasticity
Lead sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo- and active-controlled
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

1. Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.
2. Weight ≥ 50 kg.
3. Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to randomized enrollment) exhibiting upper limb spasticity.
4. 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).
5. If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
6. 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.

Exclusion Criteria:

1. History of allergy to any component of the experimental drugs.
2. Previous use of any botulinum toxin within 6 months prior to randomized enrollment, or plan to use other botulinum toxins not specified in the study protocol during the study.
3. Fixed contractures of the studied limb.
4. Any medical condition that may increase the risk to the subject when using Botulinum Toxin Type A.
5. Need for treatment with drugs that interfere with neuromuscular function during the study.
6. Plan or anticipate to use new antispasticity drugs during the study.
7. History of epilepsy.
8. Pregnant or breastfeeding women. Participation in other drug/device clinical trials within 1 month prior to randomized enrollment.

Primary outcomes:
measure: Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4
timeFrame: Week 4 after treatment
Secondary outcomes:
measure: Physician's Global Assessment (PGA) Score at Week 1, Week 4, Week 8 and Week 12
timeFrame: Week 1, Week 4, Week 8 and Week 12 after treatment
measure: Change From Baseline in MAS Score of Primary Target Clinical Pattern at Week 1, Week 8, Week 12
timeFrame: Week 1, Week 8 and Week 12 after treatment
measure: Response Rates on MAS Calculated for the Primary Target Clinical Pattern at Week 1, Week 4, Week 8 and Week 12
timeFrame: Week 1, Week 4, Week 8 and Week 12 after treatment
measure: Changes From Baseline in Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain at Week 1, Week 4, Week 8 and Week 12
timeFrame: Week 1, Week 4, Week 8 and Week 12 after treatment
measure: Incidence of Adverse Events and Serious Adverse Events
timeFrame: Within 12 weeks of treatment
measure: Incidence of Anti-drug Antibodies and Neutralizing Antibodies
timeFrame: Within 12 weeks of treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Kaifeng
country: China
facility: The First Affiliated Hospital of Henan University
state: Henan
city: Wuhan
country: China
facility: RenMin Hospital Of Wuhan University
state: Hubei
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Medical University Affiliated Hospital
state: Jiangsu
city: Qingdao
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Rui Jin Hospital of Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Fudan University HuaShan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Yangzhi Affiliated Rehabilitation Hospital of Tongji University
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi provincial people's Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital，Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xinhua Wan
role: PRINCIPAL_INVESTIGATOR
References: