A Phase II Study on Recombinant Botulinum Toxin Type a (YY001) for Injection in the Treatment of Upper Limb Spasticity in Adults

Phase 2

Recruiting

• Conditions: Upper Limb Spasticity
• Interventions: Biological: Recombinant Botulinum Toxin Type A for injection (YY001); Biological: BOTOX®; Biological: Placebo

• Registration Number: NCT06783114
• Lead Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-14
• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-03-18
• Study Completion: 2025-05-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Recombinant Botulinum Toxin Type A for injection (YY001)	Single injection with Recombinant Botulinum Toxin Type A for injection (YY001) in upper limb spasticity
Active-Controlled Group	BOTOX®	Single injection with BOTOX® in upper limb spasticity
Placebo-Controlled Group	Placebo	Single injection with placebo in upper limb spasticity

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4	Week 4 after treatment	Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed elbow or flexed wrist or clenched fist.; The Modified Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 6-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Secondary Outcome Measures

Name	Time	Method
Physician's Global Assessment (PGA) Score at Week 1, Week 4, Week 8 and Week 12	Week 1, Week 4, Week 8 and Week 12 after treatment	The Physician's Global Assessment is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point scale that ranges from -3 = very much worse to +3 = very much improved.
Change From Baseline in MAS Score of Primary Target Clinical Pattern at Week 1, Week 8, Week 12	Week 1, Week 8 and Week 12 after treatment
Response Rates on MAS Calculated for the Primary Target Clinical Pattern at Week 1, Week 4, Week 8 and Week 12	Week 1, Week 4, Week 8 and Week 12 after treatment	Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed elbow or flexed wrist or clenched fist.; Subjects with a MAS reduction of one point were defined as responder.
Changes From Baseline in Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain at Week 1, Week 4, Week 8 and Week 12	Week 1, Week 4, Week 8 and Week 12 after treatment	The DAS consists of the four domains hygiene, dressing, limb position and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Incidence of Adverse Events and Serious Adverse Events	Within 12 weeks of treatment
Incidence of Anti-drug Antibodies and Neutralizing Antibodies	Within 12 weeks of treatment

Trial Locations

Locations (19)

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

RenMin Hospital Of Wuhan University; 🇨🇳 Wuhan, Hubei, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Qilu Hospital of Shandong University; 🇨🇳 Qingdao, Shandong, China

Shanxi Bethune Hospital; 🇨🇳 Taiyuan, Shanxi, China

West China Hospital，Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

The Second Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China

The Second People's Hospital of Hefei; 🇨🇳 Hefei, Anhui, China

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China

Xuzhou Medical University Affiliated Hospital; 🇨🇳 Xuzhou, Jiangsu, China

Shanghai Fudan University HuaShan Hospital; 🇨🇳 Shanghai, Shanghai, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Yangzhi Affiliated Rehabilitation Hospital of Tongji University; 🇨🇳 Shanghai, Shanghai, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

The First Affiliated Hospital of Henan University; 🇨🇳 Kaifeng, Henan, China

Rui Jin Hospital of Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanxi provincial people's Hospital; 🇨🇳 Taiyuan, Shanxi, China