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This is an open-label, multicenter, phase III clinical study to evaluate the long-term safety and efficacy of multiple treatments with recombinant botulinum toxin type A (YY001) for injection in adult upper limb spasticity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant botulinum toxin type A (YY001) | Experimental | Multiple injection with recombinant botulinum toxin type A for injection (YY001) in upper limb spasticity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant botulinum toxin type A for injection (YY001) | Biological | Prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose for single treatment is 200 to 400 U. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events and Serious Adverse Events | Up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment (PGA) Score | 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. | Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieru Bai | Contact | +86 13883955310 | bai.jieru@claruvis.com | |
| Xiaoyun Sun | Contact | sun.xiaoyun@claruvis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| Change From Baseline in MAS Score of Primary Target Clinical Pattern |
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). |
| Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment |
| Response Rates on MAS Calculated for the Primary Target Clinical Pattern | 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. | Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment |
| The Proportion with Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain Score Reduction of ≥1 Point | 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). | Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment |
| Incidence of Anti-drug Antibodies and Neutralizing Antibodies | Up to 48 weeks |
| West China Hospital,Sichuan University | Recruiting | Chengdu | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangdong | China |
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| Sun Yat-sen Memorial Hospital | Recruiting | Guangzhou | China |
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| The Second People's Hospital of Hefei | Recruiting | Hefei | China |
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| Huai'an First Hospital Affiliated to Nanjing Medical University | Recruiting | Huai'an | China |
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| The First Affiliated Hospital of Henan University | Recruiting | Kaifeng | China |
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| The Second Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | China |
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| Shanghai Fudan University HuaShan Hospital | Recruiting | Shanghai | China |
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| Yangzhi Affiliated Rehabilitation Hospital of Tongji University | Recruiting | Shanghai | China |
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| Shenzhen Second People's Hospital | Recruiting | Shenzhen | China |
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| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | China |
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| Shanxi Bethune Hospital | Recruiting | Taiyuan | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | China |
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| Xuzhou Medical University Affiliated Hospital | Recruiting | Xuzhou | China |
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| Zibo Municipal Hospital | Recruiting | Zibo | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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