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
Secondary identifying numbers BIO057 RSU/441418
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
29/11/2013
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

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study hypothesisNot provided at time of registration
Ethics approval(s)Not provided at time of registration
ConditionCerebral palsy
InterventionBotulinum toxin vs placebo
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date10/01/2000
Overall study end date31/01/2003

Eligibility

Participant type(s)Patient
Age groupChild
SexNot Specified
Target number of participantsNot provided at time of registration
Participant inclusion criteriaChildren with spastic diplegia or hemiplegia
Participant exclusion criteriaNot provided at time of registration
Recruitment start date10/01/2000
Recruitment end date31/01/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St James' University Hospital
Leeds
LS9 7TF
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (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