Chronic Hip Pain due to Cerebral Palsy
Conditions
Interventions
Trade Name: Dysport
Product Name: Dysport
Pharmaceutical Form: Injection*
INN or Proposed INN: Clostridium botulinum type A toxin - haemagglutinin complex
Concentration number: 500 units / vial-
Sponsors
Ipsen Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written (personally signed and dated) informed consent given by the patient’s parent or guardian. Written informed assent given by the patient (if possible). Male or female aged between 4 and 16 years (inclusive). Diagnosis of cerebral palsy. Presence of clinical hip pain (of at least 6 months duration) due to cerebral palsy as defined by the child and/or parents. Paediatric Pain Profile score of 25 or greater. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior treatment with Botulinum toxin (any serotype, administered anywhere in the body) within 4 months prior to Screening. Pregnancy or lactation. Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude, unless the disease under study is such that the patient presents with such symptoms and the consent of a legal guardian or carer must be sought (providing the latter is permitted by the local legislation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/painful hip) in the management of chronic hip pain due to cerebral palsy in children/young people. The primary endpoint will be the change in score in the Paediatric Pain Profile from Baseline to the Week 4 assessment. A responder will be defined as having a 20 point reduction in the Paediatric Pain Profile score.;Secondary Objective: • To compare the three treatment groups of the change in Paediatric Pain Profile Score following treatment with Dysport from Baseline to Week 12 and Week 16. • To compare the treatment groups of the change in sleep pattern and quality (length of time taken to get to sleep each night, frequency of waking during the night, total duration of sleep per night, sleep patterns during the day) from Baseline to Weeks 4, 12 and 16 as assessed using the sleep diary. • To compare the treatment groups of the change in sleep questionnaire score from Baseline to Weeks 4 and 16. • To compare the treatment groups of the change in oral analgesia intake at all assessment time points after the study treatment. • To compare the treatment groups of the change in hip range of movement from Baseline to Weeks 4, 12 and 16. • To compare the treatment groups of the duration of efficacy, defined as return of clinically significant pain. ;Primary end point(s): The primary efficacy variable is a comparison between the three treatment groups of the change in Paediatric Pain Profile Score following study treatment with Dysport from Baseline to Week 4. Responders are defined as those patients who achieve a reduction of 20 points or more. | — |
Countries
United Kingdom
Outcome results
None listed