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The aim of this clinical study is to investigate the efficacy and safety of Dysport® in patients with early onset of upper limb spasticity within 2-12 weeks after stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dysport |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | 1 injection, 500 U at day 0. The study will last for 6 months in each patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of spasticity assessed by changes of the Modified Ashworth Spasticity Score from baseline of elbow and wrist flexors in supine anatomical position | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of neurologic outcome (mobility and function), evaluated by Modified Ashworth Scale, Barthel Index, Modified Rankin scale, Functional scale (Motor Assessment Scale) | weeks 4, 8, 12 & 24 | |
| Voluntary and passive joint range of motion goniometer assessment |
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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 |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Shatin | Hong Kong | ||||
| University Hospital of Malaya Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22371239 | Result | Rosales RL, Kong KH, Goh KJ, Kumthornthip W, Mok VC, Delgado-De Los Santos MM, Chua KS, Abdullah SJ, Zakine B, Maisonobe P, Magis A, Wong KS. Botulinum toxin injection for hypertonicity of the upper extremity within 12 weeks after stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2012 Sep;26(7):812-21. doi: 10.1177/1545968311430824. Epub 2012 Feb 27. |
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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 |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Placebo | Drug | 1 injection at day 0. The study will last for 6 months in each patient. |
|
| weeks 4, 8, 12 & 24 |
| Pain Assessment using visual analogue scale for pain | weeks 4, 8, 12 & 24 |
| Kuala Lumpur |
| 59100 |
| Malaysia |
| University of Santo Tomas | Manila | 3001 MAB | Philippines |
| TTSH Rehabilitation Centre | Singapore | 569766 | Singapore |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| 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 |