Condition category
Nervous System Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
04/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Publication citations

Additional files

Editorial Notes

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