ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12605000379617

Ethics application status

Approved

Date submitted

8/09/2005

Date registered

13/09/2005

Date last updated

13/09/2005

Type of registration

Retrospectively registered

Titles & IDs

Public title

Botulinum toxin injections into the salivary glands to reduce drooling in children

Scientific title

A randomised trial of botulinum toxin injections into the submandibular and parotid glands to reduce drooling in children with neurological disorders

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Excessive drooling in children with neurological disorders

Condition category

Condition code

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Single Injection of botulinum toxin A into submandibular and parotid glands (25 units per gland) x 1

Comparator / control treatment

Control group

Placebo

Outcomes

Primary outcome [1]

Questionnaire on frequency, severity and impact of drooling will be administered by phone

Timepoint [1]

At one month post injection, and each successive month for 6 months

Secondary outcome [1]

None

Timepoint [1]

Eligibility

Key inclusion criteria

Problem with drooling Guardians able to understand study requirements and give informed consent.

Minimum age

6 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Previous botulinum toxin therapy to salivary glandsPrevious saliva control surgeryAny BTX-A treatment in previous 6 monthsNot fit enough to undergo general anaesthesiaUnwillingness to go off drooling medication for length of study.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

R randomisation plan from http://www.randomization.com was used to generate the randomised sequence in 2 blocks stratified by centre

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/10/2004

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Allergan P/L

Address [1]

Country [1]

Primary sponsor type

Other

Name

Murdoch Children's Research Institute

Address

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Royal Children's Hospital, Melbourne

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Children's Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Southern Health

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Summary

Brief summary

Children with cerebral palsy and other neurological impairments frequently have inadequate saliva control. The secretions may be odorous, cause chronic irritation of the facial skin and may damage clothing and books. Poor saliva control results in loss of self-esteem and can impede community inclusion. Conventional treatments include speech pathology intervention, the use of medication and surgical procedures. These interventions are not universally successful, and may be invasive (surgery) or lead to unwanted side effects (surgery and medication).  

There have been recent reports about the use of Botulinum toxin A (BTX-A), in the treatment of drooling. BTX-A is widely used as a treatment for spasticity in children with cerebral palsy, blocks the release of acetylcholine at the neuromuscular junction and selectively weakens the muscles for three to six months. This drug can be injected directly into the salivary glands under a general anaesthetic with ultrasound guidance. Within one to three days the drug binds on to the nerve endings and reduces the amount of saliva being produced from the injected salivary glands. Reports of the use of BTX-A are still limited with small groups of subjects, and include reports of studies in both adults and children, and also the injection of different combinations of glands in the various studies. 

The aim of our study is to assess the effectiveness of injections into the submandibular and parotid glands in a cohort of children with cerebral palsy and other neurological disorders. A randomised controlled study will be undertaken with children being allocated to either receive BTX-A at the start of the trial, or to a control group able to receive treatment at the conclusion of the six month study period. Measures will be undertaken at baseline for both groups, then at monthly intervals for six months. A sample size of 28 children per group will be required.  

Children will be recruited from the Saliva Control Clinic at the Royal ChildrenÃ¿Â¿Ã¿Â¢Ã¿Â¿Ã¿Â¿Ã¿Â¿Ã¿Â¿s Hospital and a cohort will also be recruited from the Monash Medical Centre (a separate ethics application will be made). BTX-A will then be injected into both submandibular and sublingual glands with ultrasound guidance. A short general anaesthetic will be necessary. 

Statistical analysis will be undertaken to determine the effectiveness of BTX-A in reducing poor saliva control. Adverse effects will be reported, and in particular, the views of parents will be established by means of a questionnaire.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

A/Professor Dinah Reddihough

Address

Child Development and Rehabilitation
Royal Children's Hospital
Parkville VIC 3052

Country

Australia

Phone

+61 3 93455898

Fax

dinah.reddihough@rch.org.au

Contact person for scientific queries

Name

Sue Reid

Address

Child Development and Rehabilitation
Royal Children's Hospital
Parkville VIC 3052

Country

Australia

Phone

+61 3 93454807

Fax

sue.reid@mcri.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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