Condition category
Nervous System Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
23/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R Morton

ORCID ID

Contact details

c/o Derby Children's Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 340131
richard.morton@derbyhospitals.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0171133935

Study information

Scientific title

Acronym

Study hypothesis

How can injection technique be improved to increase efficacy per dose of botulinum toxin, as measured by observational gait analysis.

This study will examine whether multiple injection technique treatment is more effective than single injection technique, for spastic muscle in children with cerebral palsy. We shall examine the effect of dividing the standard treatment of single injections of Botulinum to the Gastrocnemius muscle into multiple smaller injections.
We shall also compare discomfort at time of injection, by standardised child and parent reporting scales.

Null hypothesis - there is no difference in efficacy or adverse effects between single versus multiple injections.

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

Randomised Controlled Trial.

Children are recruited to the study and consent is signed by themselves and/or their carers. They are randomised to group A or group B.

Group A:
Proceed first to single injections to the gastrocnemius 2 cm each side of the midline, one fifth of the distance from the tibial condyles to the ankle malleoli. A total dose of Botulinum A (Dysport) of 12 Units/kg, to a maximum 500 Units, is given in two divided fractions, using a concentration of Botulinum A (Dysport) 500 Units in 5 ml N saline.
Six months later they receive the same total dose of Botulinum A at the same concentration but divided into 10 fractions. Five injections are given 2 cm on either side of the midline of the muscle and evenly spaced, starting one fifth of the distance from the tibial condyles to the ankle malleoli and ending just past the major bulge of the gastrocnemius muscle.

Group B:
First receive the multiple injections, then six months later single injections using the same techniques as for Group A.

For each injection, the injected area of skin is treated with local anaesthetic gel (Amethocaine), 1 hour beforehand. Thirty minutes before injection, they are given oral midazolam 0.7 mg/kg as relaxant, and oral diclofenac 1 mg/kg as analgesic.

Intervention type

Drug

Phase

Not Applicable

Drug names

Botulinum A (Dysport)

Primary outcome measures

1. Efficacy of Botulinum toxin injection to that muscle, as assessed by observational gait scale, before at 4 weeks and at 12 weeks
2. The discomfort at the time of injection

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2003

Overall trial end date

01/12/2005

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

20, 4-12 year old children. Boys and girls with cerebral palsy (hemiplegia and diplegia)

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/12/2003

Recruitment end date

01/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

c/o Derby Children's Hospital
Derby
DE22 3NE
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

Other

Funder name

Nottingham Primary Care Research Partnership (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