What is this research study about?
The findings of this study will be used to investigate whether bumetanide might be a helpful medication for some autistic children, and also to assess the safety of the medication.
Who can take part?
The research team for this study are seeking to recruit participants who;
- are aged 2 to less than 18 years old,
- have been diagnosed with level 2 or 3 autism, and
- have no other medical conditions.
Who is conducting this study?
This study is funded by Servier Laboratories Pty Ltd.
Researchers from The Royal Children’s Hospital, Liverpool Hospital in Sydney, and Murdoch Children’s Research Institute are running this study.
What will I be asked to do?
The trial lasts about 15 months and involves 21 visits to the hospital (weekly visits during month 1 and month 6, otherwise visits are once a month).
- Each child will be treated for 12 months. For the first 6 months one half of the children will take 0.5mg bumetanide twice daily and the other half will take placebo (pretend medicine) twice daily.
- For the second 6 months ALL children will take the active treatment bumetanide.
- A new liquid form of bumetanide for children, taken by mouth, is being tested.
- Throughout the trial the research team will be assessing the presentation of your child’s autism, checking the safety of the treatment and assessing quality of life.
- The assessments include the CARS test and 2 other recognised tools that help to assess autism. There are forms for specialists and for parents and children to complete.
- The safety assessments include blood tests to check general health and for a possible drop in potassium levels, measurement of blood pressure, heart tests (ECG) and kidney tests (ultrasound).
When and where?
The trial is taking place at both The Royal Children’s Hospital Melbourne, and Liverpool Hospital Sydney.
To find out more about the study and register to participate please contact Kylie Crompton (Melbourne) or Alicia Montgomery (Sydney).
Please feel free to forward this information to others who might also be interested in participating.