Contact information
Type
Scientific
Primary contact
Prof Chris Ward
ORCID ID
Contact details
Southern Derbyshire Acute Hospitals NHS Trust
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 340141 Ext 5680
c.d.ward@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RBF 96X23
Study information
Scientific title
Acronym
Study hypothesis
Is 24 ng Dysport/Kg body weight more efficacious than 8 ng Dysport/Kg (using impairment measures)
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
Nervous system diseases: Cerebral palsy
Intervention
1. 24 ng Dysport/kg body weight
2. 8 ng Dysport/kg (using impairment measures)
Intervention type
Drug
Phase
Not Applicable
Drug names
Botulinum toxin (Dysport)
Primary outcome measures
1. Impairment measure using gait analysis
2. Gastrocnemius muscle length was calculated at each visit using the method described by Eames and used as primary outcome measure
Secondary outcome measures
Secondary outcome variable was maximum ankle angle measured during stance and swing phases.
Overall trial start date
01/03/1997
Overall trial end date
31/07/2000
Reason abandoned
Eligibility
Participant inclusion criteria
Children with hemiplegic cerebral palsy
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/1997
Recruitment end date
31/07/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Trent (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
Results in http://www.ncbi.nlm.nih.gov/pubmed/12206622
Publication citations
-
Results
Polak F, Morton R, Ward C, Wallace WA, Doderlein L, Siebel A, Double-blind comparison study of two doses of botulinum toxin A injected into calf muscles in children with hemiplegic cerebral palsy., Dev Med Child Neurol, 2002, 44, 8, 551-555.