A prospective randomised double blind study of dosage efficacy of Botox® Vs Dysport® in children with spastic diplegic cerebral palsy (CP)

ISRCTN ISRCTN34438724
DOI https://doi.org/10.1186/ISRCTN34438724
Secondary identifying numbers N0123134254
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
02/05/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Andrew Furlong
Scientific

University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom

Phone +44 (0)116 258 4109
Email andrew.furlong@uhl-tr.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA prospective randomised double blind study of dosage efficacy of Botox® Vs Dysport® in children with spastic diplegic cerebral palsy (CP)
Study objectivesTo determine the efficacy ratio of Botox® and Dysport® in spastic cerebral palsy for comparable outcomes.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCerebral palsy
InterventionRandomised controlled trial to determine the dosage efficacy of Botox versus Dysport in spastic cerebral palsy.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Botulinum toxin type A (Botox®, Dysport®)
Primary outcome measureFunctional improvement at 12 months, need for further injections
Secondary outcome measuresNot provided at time of registration
Overall study start date17/12/2003
Completion date06/06/2004

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaSpastic diplegic symmetrical CP children with >2 + equinus deformity or tight hamstrings
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment17/12/2003
Date of final enrolment06/06/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

University Hospitals of Leicester NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

02/05/2018: No publications found, verifying study status with principal investigator.
04/03/2016: No publications found, verifying study status with principal investigator.