Current phase of trial: Phase 2
Type of MS: Secondary progressive MS
Find out more about fluoxetine
How does fluoxetine work?
Fluoxetine is a selective serotonin reuptake inhibitor (SSRI). It increases the amount of serotonin, a chemical messenger thought to influence mood, in the brain by preventing it from being absorbed.
How is fluoxetine taken?
Fluoxetine is a tablet.
MS-SMART was a phase 2 trial that tested the potential of three different drugs - riluzole, amiloride and fluoxetine - in 440 people with secondary progressive MS.
The top-line results of MS-SMART were announced in October 2018.
Unfortunately, none of the three drugs that were tested showed the potential to slow disability progression in MS.
FLUOX-PMS is a phase 2 trial that involved 134 people with primary and secondary progressive MS. It tested how effectively fluoxetine could slow progression compared to a placebo. Topline results from this trial were announced at a scientific conference in September 2016. Researchers found that fluoxetine did not slow progression compared with placebo.
In 2007, we set up the UK MS Clinical Trials Network (CTN): a group of MS experts tasked with developing and producing clinical trials for progressive MS. The group, funded by the MS Society, carried out £500,000 worth of underpinning research that was needed in order to develop the MS-SMART trial.
Through the work of the CTN, a number of drugs were established as having the potential to be neuroprotective, of which fluoxetine scored particularly highly.
Fluoxetine has shown promise in early phase clinical trials in people with MS. Two trials have tested fluoxetine as a treatment for people with MS (one for relapsing and one for progressive MS). Fluoxetine was found to be safe in the progressive MS trial, and was reported to reduce the number of lesions in the brain in 40 people with relapsing MS.
What are the side effects of fluoxetine?
The side-effects of fluoxetine will be published alongside the full results of the MS-SMART trial.
Commonly reported side effects from people using it to treat other conditions include nausea, anxiety, sleep problems, headache and dizziness.
How does fluoxetine compare with other therapies?
Right now there are no effective treatments for secondary progressive MS. The results of the MS-SMART trial have shown that fluoxetine is not an effective treatment for MS.
When is fluoxetine likely to become available?
The MS-SMART trial finished in 2018. The results showed that fluoxetine is not an effective treatment for MS. The trial was extremely well conducted, meaning these results are robust and we therefore now know not to pursue these drugs any further.
This means that fluoxetine will not be taken forward to further clinical trials, and will not become available as a treatment for MS.