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Summary
EudraCT Number:2005-005197-78
Sponsor's Protocol Code Number:1
National Competent Authority:UK - MHRA
Clinical Trial Type:EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:2006-07-22
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedUK - MHRA
A.2EudraCT number2005-005197-78
A.3Full title of the trial
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
A.3.2Name or abbreviated title of the trial where available
Comparison of Gastrocnemius Injection Techniques in CP
A.4.1Sponsor's protocol code number1
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorQueen's Medical Centre, Nottingham, University Hospital NHS Trust,
B.1.3.4CountryUnited Kingdom
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameDysport
D.3.4Pharmaceutical form Powder for injection*
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNClostridium botulinum type A toxin - haemagglutinin complex
D.3.10 Strength
D.3.10.3Concentration number500 Units/vial
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Yes
D.3.11.13.1Other medicinal product typeToxin
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Spasticity of the Gastrocnemius Muscle due to Cerebral Palsy
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 8.0
E.1.2Level LLT
E.1.2Classification code 10024132
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
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.
E.2.2Secondary objectives of the trial
- 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.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal 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.
E.4Principal 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.
E.5 End points
E.5.1Primary 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.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group Yes
E.8.1.6Cross over Yes
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other Yes
E.8.2.3.1Comparator description
Dysport
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee Information not present in EudraCT
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
The last visit of the last subject undergoing the trial.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months0
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) Yes
F.1.1.6Adolescents (12-17 years) Yes
F.1.2Adults (18-64 years) No
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Yes
F.3.3.6.1Details of subjects incapable of giving consent
Children under 18 years of age
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state20
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
Patients will receive the usual medical care for their condition which may include Dysport injections if appropriate.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2006-07-31
N.Ethics Committee Opinion of the trial application
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial Status

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