A multi-centre, randomised, parallel group, cross-over study comparing the efficacy and safety of double versus multiple injections of Botulinum Toxin type-A (Dysport®), into the gastrocnemius muscle of children with cerebral palsy - Comparison of Gastrocnemius Injection Techniques in CP

Queen's Medical Centre, Nottingham, University Hospital NHS Trust,0 个研究点开始时间: 2006年7月22日最近更新: 2017年10月2日

研究概览

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•1. The patient’s legal parent/guardian must give written (personally signed and dated) informed consent, and the patient must give informed assent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal medical care.
•2. The patient must be between 4 and 12 years of age inclusive.
•3. The patient must have a diagnosis of hemiplegic or diplegic cerebral palsy.
•4. The patient must be able to walk with or without the use of aids.
•5. The patient must have spasticity of the Gastrocnemius muscle on one or both sides, as measured by an inability to achieve heel strike due to lower limb spasticity predominantly affecting the calf muscles.
•6. The patient and his/her parent/guardian must be able and willing to comply with the requirements of the protocol.
•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

•1. The patient has calf muscle contractures preventing dorsiflexion of the foot to less than the neutral position with the knee straight.
•2. The patient also needs treatment to the adjacent Soleus or Tibialis Posterior muscles.
•3. The patient needs treatment to the hamstring muscles on the same side as the treated Gastrocnemius muscle.
•4. The patient has had prior lower limb orthopaedic surgery in the previous year.
•5. The patient has severe athetoid movements of the lower limbs.
•6. Previous injection with Botulinum toxin within 6 months prior to inclusion in the study.
•7. The patient has a known allergy or hypersensitivity to any of the test compounds or materials.
•8. The patient has received any investigational drug therapy within 30 days prior to the study, or is scheduled to receive such a drug during the study period.
•9. The patient has previously entered this study.

发起方

Queen's Medical Centre, Nottingham, University Hospital NHS Trust,