Spasticity of the Gastrocnemius Muscle due to Cerebral Palsy MedDRA version: 8.0 Level: LLT Classification code 10024132
Conditions
Interventions
Product Name: Dysport
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Clostridium botulinum type A toxin - haemagglutinin complex
Concentration number: 500 Units/vial-
Sponsors
Queen's Medical Centre, Nottingham, University Hospital NHS Trust,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether BoNT-A treatment of the gastrocnemius muscle is more effective in the reduction of spasticity if it is administered by multiple injections (test) or the standard double injection technique (reference). This will be determined by analysing the change in gait 4 weeks after each treatments using the physician's rating index.;Secondary Objective: - Comparison of the change in gait at all other assessment timepoints. - Comparison of patient, parent and nurse pain scores (using FACES and VAS scales) for the two injection techniques. - Comparison of the safety of the two injection techniques.;Primary end point(s): Change in gait (assessed using the Physician's rating Index) 4 weeks after each treatment. A clinically relevant difference between the multiple injection (test) technique and the double injection (reference) technique, would be an additional 1 point improvement in the Physician's rating index for the test intervention over the reference intervention. | — |
Countries
United Kingdom
Outcome results
None listed