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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001794-10 | EudraCT Number |
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Low levels of recruitment
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The purpose of the study is to compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport 5 units | Experimental |
| |
| Dysport 10 units | Experimental |
| |
| Dysport 15 units | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people. | From baseline to the end of study (week 20) | |
| The primary endpoint will be the change in score in the Paediatric Pain Profile. | From baseline to the week 4 assessment |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of hip pain as assessed by the change in the score of the Paediatric Pain Profile at all other assessment time points. | Weeks 12, 16 and 20 | |
| To compare the effect of the different doses of Dysport on sleep pattern and quality as assessed using a sleep diary and sleep questionnaire at all assessment time points. |
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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 |
|---|---|---|---|---|---|---|
| Chailey Heritage Clinical Services | Chailey | BN8 4JN | United Kingdom |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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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| Weeks 4, 12, 16 and 20 |
| To compare the effect of the different doses of Dysport on oral analgesia intake for hip pain at all assessment time points. | Weeks 4, 12, 16 and 20 |
| 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 |