Do you have multiple sclerosis and one or both of your arms shake?

The TREMTOX study: A clinical trial to assess the effectiveness and safety of Botox injections for arm shaking in multiple sclerosis

The purpose of this study is to assess the effectiveness and safety of commonly used doses of Botulinum toxin (Botox) on arm shaking (or tremor) in people with multiple sclerosis (MS).

We have previously done a smaller study showing that Botox can improve tremor. However, to make Botox available on the PBS, we need to do this larger study. The initial assessment and injections are randomized so that you have a 50:50 chance to get Botox or placebo (water). To ensure everyone in the study gets at chance to see if Botox works we do a set of Botox injections at the 6-month mark. You may also be asked to have two MRI scans of your brain that will help us work out how and why some people with MS develop tremor.

Anticipated date that enrolment will close: May 2018

Who can take part

  • You have a diagnosis of RRMS, SPMS or PPMS and aged between 18 and 65 years
  • You no other neurological disease to explain presence of tremor

You cannot take part in the study if you are:

  • allergic to Botox
  • have had other Botox injections in the last 6 months
  • presently taking strong blood thinners, for example, warfarin
  • pregnant, breastfeeding or unwilling to use adequate contraception

What is involved for you

  • The study takes 48 weeks (approximately 1 year) to complete and you will have to come to RMH 5 times over the year.
  • If you are in the MRI study, you will have a MRI Brain at the Murdoch Children’s Research institute at your first visit and again and the second visit, 6 weeks later. Injections are done at the first visit and again at the 6-month visit. The visits take approximately 1 hour.

Other assessments include:

  • A detailed clinical history and neurological examination
  • An assessment of your arms including doing tasks such as writing, drawing and pouring water
  • An assessment of your speech pattern that requires you to read a paragraph and repeat some sentences
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Non-Drug
Phase 1
Phase 2
Phase 3
Phase 4

For more information

Quote reference number
2015.069
Lisa Taylor
03 9342 7061
Sandra Williams
03 9342 9092