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This is a phase III clinical study to evaluate the efficacy and safety of recombinant botulinum toxin type A(Eveotox)in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of Eveotox compared with placebo in adult patients with upper limb spasticity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | Eveotox will be administered in double-blind fashion at cycle 1 followed by up to 3 open-label cycles of Eveotox. |
|
| Placebo-Controlled Group | Placebo Comparator | Placebo will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 cycles of Eveotox. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Botulinum Toxin Type A for injection | Drug | Recombinant Botulinum Toxin Type A for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale). | Within 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measure | Incidence of adverse events and drug-related adverse events during the study. | Within 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danhua Lin | Contact | 15811460241 | danhua.lin@jhm-biopharma.com | |
| Lei Wang | Contact | lei.wang@jhm-biopharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | China |
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Double-blinded
| Placebo | Drug | Placebo will be administered in double-blind fashion during treatment cycle 1 only |
|
| Yangzhi Affiliated Rehabilitation Hospital of Tongji University | Shanghai | Shanghai Municipality | China |
|
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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