Contact information
Type
Scientific
Primary contact
Mr Andrew Furlong
ORCID ID
Contact details
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
+44 (0)116 258 4109
andrew.furlong@uhl-tr.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0123134254
Study information
Scientific title
A prospective randomised double blind study of dosage efficacy of Botox® Vs Dysport® in children with spastic diplegic cerebral palsy (CP)
Acronym
Study hypothesis
To determine the efficacy ratio of Botox® and Dysport® in spastic cerebral palsy for comparable outcomes.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cerebral palsy
Intervention
Randomised controlled trial to determine the dosage efficacy of Botox versus Dysport in spastic cerebral palsy.
Intervention type
Drug
Phase
Not Specified
Drug names
Botulinum toxin type A (Botox®, Dysport®)
Primary outcome measures
Functional improvement at 12 months, need for further injections
Secondary outcome measures
Not provided at time of registration
Overall trial start date
17/12/2003
Overall trial end date
06/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Spastic diplegic symmetrical CP children with >2 + equinus deformity or tight hamstrings
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
17/12/2003
Recruitment end date
06/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospitals of Leicester NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary