Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2008
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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes