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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002327-42 | EudraCT Number |
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The study was withdrawn prior to enrollment due to corporate decision.
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This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| onabotulinumtoxinA Dose 1 | Experimental | Up to 4 treatments of onabotulinumtoxinA Dose 1 injected into muscles of the study limb on fulfillment of the retreatment criteria. |
|
| onabotulinumtoxinA Dose 2 | Experimental | Up to 4 treatments of onabotulinumtoxinA Dose 2 injected into muscles of the study limb on fulfillment of the retreatment criteria. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Biological | Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Treated Muscle Groups Using a 6-Point Scale | Baseline, Up to 60 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale | Baseline, Up to 60 Weeks | |
| Change from Baseline in Pain on an 11-Point Scale | Baseline, Up to 60 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score | Baseline, Up to 60 Weeks |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| 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 |