E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post Operative Pain in Cerebral Palsy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054710 |
E.1.2 | Term | Post Operative Hip Pain |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008129 |
E.1.2 | Term | Cerebral Palsy |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the benefit to children with cerebral palsy of having botulinum toxin injections prior to major hip surgery, in order to reduce their post-operative pain.
To describe the pain experience of children with cerebral palsy undergoing major hip surgery. |
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E.2.2 | Secondary objectives of the trial |
Secondary outcome measures: length of stay, return to school, tolerance of sitting,transfusion requirements and quality of life. We will collect information on pain throughout the course of the study which will generate a comprehensive description of the patient's pain experience. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The child has displaced hips requiring bony orthopaedic surgery (osteotomy) due to cerebral palsy. 2. The child is between the ages of 2 and 18 years. 3. The child has a GMFCS level of IV or V 4. The child has a diagnosis of hypertonic cerebral palsy (or a diagnosis consistent with this nomenclature) 5. The child does not communicate verbally 6. Informed consent to participate has been given by parent/carer.
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E.4 | Principal exclusion criteria |
1. The child is younger than 2 years or older than 18 years 2. The child has an acute and current systemic infection or illness 3. The child has had botulinum toxin injections within the past 4 months 4. The child has had a previous reaction to botulinum toxin 5. The child has received or is likely to receive, at the time of trial drug or placebo administration, medications which might interact with botulinum toxin (this does not apply to any drugs at present) 6. Insufficient understanding of the trial by the parent or carer, in the investigator’s opinion.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in pain score during the six weeks following the operation |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last Patient Last Visit (6 months after last patient has undergone operation) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |