- What is the eligibility criteria?
Among others, prospective participants’ need
a diagnosis of Secondary Progressive Multiple Sclerosis (minimum of 2 years)
evidence of with progression of the disease (not relapses)
- How long is the trial?
Recruitment is expected over 2 years
Each participant is in trial for 3 years
Overall we expect the trial to be 5 years
- How many visits in total?
For most this will be 11 visits during the 3 years
- How frequent are the visits?
Screening, Baseline and the 1st follow up visit will be roughly monthly for 1st three months
A telephone call is completed at 3 months
Thereafter visits are every 6 months
- Who will be at the visits?
Members of the study team including: research nurses; clinical research fellows both treating physicians and independent assessors
Will also have a strong admin support team who will help book appoints either at the visit or by telephone, they will also help sort out travel re-imbursement
- Will there be travel reimbursement available?
The study has a small allowance towards travel per visit
- Will transport be booked for travelling to NHNN for trial?
No. Participants will be required to make their own travel arrangements but a small contribution can be made towards their travel costs
- Participant Withdrawal
The study is completely voluntary and the participant can withdraw from the study at any point with no explanation given, and no change to their standard of care
- Which medication is used?
Simvastatin is the repurposed cholesterol drug, licensed to lower the cholesterol level in the blood. It is a common cholesterol lowering medication that has been used in millions of people around the world.
All Participants must be fully aware that they may not be on the active treatment of Simvastatin. Only 50% of participants will receive Simvastatin and 50% will receive placebo (dummy pill) as this is a double-blinded study.
- Why Simvastatin?
An earlier study (MS-STAT1) showed a likely neuroprotection effect on MRI scans.
- Will participants know what drug they are on?
No. This is a double-blinded trial meaning the treating doctors and nurses, nor the participants, will be aware of what drug they are on through the trial.
- Side effects: what to expect?
Simvastatin is generally a very safe drug. There are rare serious side-effects in a few people which will be fully discussed with all potential participants.
- Do participants need to register to the UK MS Register to take part in the trial?
No there is no obligation to sign up with the UK MS Register although we do strongly suggest this.
- Can participants take part in MS-STAT2 if they are participating in another clinical trial?
No. However when they finish their existing clinical trial, following a 6 month washout period, they could be considered for the MS STAT2 trial. A washout period is defined as the time between treatments i.e., stopping one medication and starting another.
- GDPR and MS-STAT2
Please see our GDPR pages for further informataion