Botulinum Toxin in the management of spasticity in children with cerebral palsy: a randomised double blind trial

ISRCTN	ISRCTN85066174
DOI	https://doi.org/10.1186/ISRCTN85066174
Protocol serial number	BIO057 RSU/441418
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

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

Dr Socrates Roussounis
Scientific

St James' University Hospital
Yorkshire Regional Child Development Centre
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone	+44 0113 206 5846

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cerebral palsy
Intervention	Botulinum toxin vs placebo
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/01/2003

Participant type(s)	Patient
Age group	Child
Sex	Not Specified
Key inclusion criteria	Children with spastic diplegia or hemiplegia
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	10/01/2000
Date of final enrolment	31/01/2003

St James' University Hospital

Leeds
LS9 7TF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan