A Phase 2 interventional study of Botulinum toxin type A in Cerebral Palsy, sponsored by Ipsen. Terminated at 1 site in United Kingdom. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2019-08-02.
Sponsored by Ipsen · Phase 2, Interventional, and Treatment
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.
1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.
This study's enrollment of 6 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
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Exclusion Criteria:
Biological: Botulinum toxin type A
Biological: Botulinum toxin type A
Biological: Botulinum toxin type A
Also known as: AbobotulinumtoxinA (Dysport®)
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.
Time frame: From baseline to the end of study (week 20)
The primary endpoint will be the change in score in the Paediatric Pain Profile.
Time frame: From baseline to the week 4 assessment
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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 4, 12, 16 and 20
This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Ipsen