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To compare the effectiveness and safety of Dysport® with the domestic Botulinum Toxin Type A (manufactured by Lanzhou Biologic Product Institute, P.R. China) for the treatment of hemifacial spasm.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels) | At the end of week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication) | At the end of week 1 and 12 | |
| Improvement degree of spasm (Jankovic scale) | At the end of week 1, 4 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Department, Peking Union Medical College Hospital | Beijing | 100730 | China | |||
| Neurology Department, Guangdong Provincial People's Hospital |
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| ID | Term |
|---|---|
| D019569 | Hemifacial Spasm |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Assessment of efficacy by the subjects | At the end of week 1, 4 and 12 |
| Guangdong |
| 510080 |
| China |
| Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University | Hangzhou | 310016 | China |
| Neurology Department, Shanghai Ruijin Hospital | Shanghai | 200025 | China |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |