Trial Review

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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 474 0
Condition category
Condition code
Neurological 552 552 0 0
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] 645 0
Questionnaire on frequency, severity and impact of drooling will be administered by phone
Timepoint [1] 645 0
At one month post injection, and each successive month for 6 months
Secondary outcome [1] 1337 0
None
Timepoint [1] 1337 0

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?
No
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
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 611 0
Commercial sector/Industry
Name [1] 611 0
Allergan P/L
Country [1] 611 0
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
Country
Australia
Secondary sponsor category [1] 498 0
Hospital
Name [1] 498 0
Royal Children's Hospital, Melbourne
Address [1] 498 0
Country [1] 498 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1703 0
Royal Children's Hospital
Ethics committee address [1] 1703 0
Ethics committee country [1] 1703 0
Australia
Date submitted for ethics approval [1] 1703 0
Approval date [1] 1703 0
Ethics approval number [1] 1703 0
Ethics committee name [2] 1704 0
Southern Health
Ethics committee address [2] 1704 0
Ethics committee country [2] 1704 0
Australia
Date submitted for ethics approval [2] 1704 0
Approval date [2] 1704 0
Ethics approval number [2] 1704 0

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 Childrenÿ¿ÿ¢ÿ¿ÿ¿ÿ¿ÿ¿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 35704 0
Address 35704 0
Country 35704 0
Phone 35704 0
Fax 35704 0
Email 35704 0
Contact person for public queries
Name 9595 0
A/Professor Dinah Reddihough
Address 9595 0
Child Development and Rehabilitation
Royal Children's Hospital
Parkville VIC 3052
Country 9595 0
Australia
Phone 9595 0
+61 3 93455898
Fax 9595 0
Email 9595 0
[email protected]
Contact person for scientific queries
Name 523 0
Sue Reid
Address 523 0
Child Development and Rehabilitation
Royal Children's Hospital
Parkville VIC 3052
Country 523 0
Australia
Phone 523 0
+61 3 93454807
Fax 523 0
Email 523 0
[email protected]

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.