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The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | botulinum toxin Type A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | 750 U at Visit 1 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE) | Baseline, Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score | Week 4 | |
| Physician Assessment of Cervical Dystonia Severity | Week 4 | |
| Global Assessment of Benefit by Physician |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagreb | Croatia |
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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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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| Week 4 |
| Global Assessment of Benefit by Patient | Week 4 |
| Patient Visual Analog Assessment of Pain | Week 4 |
| 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 |