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This is a randomized, double-blind, multi-center phase II/III 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Single injection with Recombinant Botulinum Toxin Type A for injection (YY001) in upper limb spasticity |
|
| Active-Controlled Group | Active Comparator | Single injection with BOTOX® in upper limb spasticity |
|
| Placebo-Controlled Group | Placebo Comparator | Single injection with placebo in upper limb spasticity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Botulinum Toxin Type A for injection (YY001) | Biological | Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200-400 U. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4 | 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). | Week 4 after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment (PGA) Score at Week 1, Week 4, Week 8 and Week 12 | 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. | Week 1, Week 4, Week 8 and Week 12 after 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, Ph.D | Contact | +86 13810399273 | sun.xiaoyun@claruvis.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinhua Wan | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Recruiting | Hefei | Anhui | China |
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Placebo- and active-controlled
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Double-blind
| BOTOX® | Biological | Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U. |
|
| Placebo | Biological | Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection. |
|
| 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 | 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. | Week 1, Week 4, Week 8 and Week 12 after treatment |
| Changes From Baseline in Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain at Week 1, Week 4, Week 8 and Week 12 | 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). | Week 1, Week 4, Week 8 and Week 12 after treatment |
| 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 |
| The Second People's Hospital of Hefei | Recruiting | Hefei | Anhui | China |
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| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Chongqing Traditional Chinese Medicine Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
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| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
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| Sun Yat-sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | China |
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| Shenzhen Second People's Hospital | Recruiting | Shenzhen | Guangdong | China |
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| The First Affiliated Hospital of Henan University | Recruiting | Kaifeng | Henan | China |
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| RenMin Hospital Of Wuhan University | Recruiting | Wuhan | Hubei | China |
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| Huai'an First People's Hospital | Recruiting | Huai'an | Jiangsu | China |
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| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China |
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| The Fourth Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China |
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| Xuzhou Medical University Affiliated Hospital | Recruiting | Xuzhou | Jiangsu | China |
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| Qilu Hospital of Shandong University | Recruiting | Qingdao | Shandong | China |
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| Zibo Municipal Hospital | Recruiting | Zibo | Shandong | China |
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| Rui Jin Hospital of Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai Fudan University HuaShan Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| Yangzhi Affiliated Rehabilitation Hospital of Tongji University | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanxi Bethune Hospital | Recruiting | Taiyuan | Shanxi | China |
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| Shanxi provincial people's Hospital | Recruiting | Taiyuan | Shanxi | China |
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| West China Hospital,Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| The Second Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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