The TREMTOX study – a clinical trial to assess the effectiveness and safety of Botox injections for arm shaking in MS.

Type of Study/Intervention

Drug

Recruitment Status

Closed

Form of MS

Relapsing remitting MS, Secondary progressive MS, Primary progressive MS

Brief summary

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 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). 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. To ensure everyone in the study gets a chance to see if Botox works, we do a set of Botox injections at the 6-month mark.

Study procedures:
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:

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

Inclusion criteria

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

Exclusion criteria

Being on strong blood thinners like warfarin
Allergy to Botox
Botox injections into the arm in the last 6 months
Pregnancy, breastfeeding or unwillingness to use adequate contraception.

Recruitment contacts

Lisa Taylor 0393429092 or lisa.taylor@mh.org.au

Further details

Full details of the trial can be found on the ANZCTR clinical trials database: http://www.ANZCTR.org.au/ACTRN12617000379314.aspx

Ethics Approval

Yes

Last updated

16/07/2019