Results From Trial of Simvastatin for SPMS Expected in 2025
MS-STAT2, a clinical trial testing whether the cholesterol-lowering medication simvastatin might slow disability progression in secondary progressive multiple sclerosis (SPMS), has finished enrollment.
A total of 964 people are now in the trial (NCT03387670), making it the largest progressive MS trial not run by a commercial company (MS-STAT2 is sponsored by University College London). Results from the trial are expected in 2025.
“We are delighted to have completed recruitment for MS-STAT2, a landmark trial for people living with secondary progressive MS,” Jeremy Chataway, PhD, a professor of neurology at University College London and chief investigator for the trial, said in a press release.
“Recruiting 964 participants to the MS-STAT2 trial is a really impressive MS research milestone, and we are grateful to each and every one of them for committing their time and energy to the trial,” said Emma Gray, PhD, assistant director of research at the MS Society.
“If successful, the trial could lead to a common, affordable statin becoming the first ever MS treatment to protect nerves,” Chataway said.
Participants will be randomly assigned to take simvastatin (40 milligrams/day for the first month and 80 mg/day thereafter), or a placebo, for three years. The main goal is to assess whether the treatment affects disability progression, as measured with the expanded disability status scale (EDSS).
“Recruiting almost 1,000 participants is an incredible achievement, especially as the pandemic halted recruitment for months, and many staff — including myself — were diverted to frontline NHS [National Health Service] duties,” Chataway said. “We have the wonderful participants to thank in helping us reach this milestone and for committing to at least three years on the trial. We’re looking forward to sharing the results in 2025.”
Gray added, “While a few treatments for early progressive MS are beginning to emerge, there are still thousands of people who have no treatment options — this trial gives our community another reason to hope. There’s still a way to go, but thanks to everyone involved, we’re on track to know by 2025 whether simvastatin could become the first neuroprotective MS treatment.”
Simvastatin is a statin, a class of medication that is widely used to help lower cholesterol. Besides that, statins have anti-inflammatory and neuroprotective properties that make them appealing candidates for treating MS.
A previous Phase 2 study called MS-STAT (NCT00647348) tested simvastatin against placebo in 140 SPMS patients for two years. Results suggested that the treatment lessened brain atrophy and slowed the progression of physical disability and cognitive decline. These benefits were independent of the medicine’s effect on cholesterol levels.
It’s not known exactly how simvastatin might be beneficial in MS. One hypothesis is that the medication could help keep brain cells healthy by improving blood flow in the brain. A Phase 2 trial called MS-OPT (NCT03896217), also sponsored by University College London, is testing this idea.
That trial aims to enroll approximately 40 people with SPMS, who will be given either simvastatin or a placebo. The study’s main goal is to assess the impact of treatment in blood flow in the brain, as measured via MRI, after 20 weeks.
MS-OPT is currently recruiting participants at University College London.