Phase 3 Trial in UK Soon to Test Statin, Simvastatin, in Slowing SPMS Progression
A large Phase 3 trial getting underway at sites across the U.K. will test the effectiveness of simvastatin, a widely used oral statin, in possibly treating secondary progressive multiple sclerosis (SPMS), the study’s sponsor, University College of London Hospitals (UCLH), announced.
The study, the largest ever undertaken for SPMS in the U.K., is named MS-STAT2 (NCT03387670). Its researchers will investigate simvastatin’s ability to slow or stop disability progression in 1,180 SPMS patients treated daily with the cholesterol-lowering medication, or placebo, for three years.
More than 30 sites across England, Scotland, Wales, Ireland and Northern Ireland will be recruiting eligible adult patients, ages 25 to 65, through 2019. Information can be found here and on the trial’s registered document.
“Simvastatin is a very promising treatment prospects for secondary progressive MS in our lifetime. People with this form of the condition have been waiting for decades for a drug that works, which is why there’s such excitement around being able to start the trial. While it’s still early days, we believe simvastatin could change lives,” Jeremy Chataway, a UCLH consultant neurologist and study leader, said in a press release.
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An earlier Phase 2 trial (NCT00647348), called MS-STAT, showed that high-dose simvastatin (80 mg daily) improved cognitive function and slowed disease progression in treated SPMS patients.
The compound was also seen to reduce the rate of brain atrophy, or shrinkage, suggesting that it may hold anti-inflammatory proprieties, protecting nerve cells from damage in SPMS.
In the Phase 3 study, patients will start by taking one simvastatin tablet (40 mg) once each night for one month followed two tablets (80 mg total) at night for the next 35 months, or take placebos. Changes in disease progression and degree of physicial and cognitive disabilities will be measured in both patient groups using EDSS (Expanded Disability Status Scale) scores taken at study’s start and again at every six months throughout the study.
Secondary study goals include changes in walking ability and upper limb dexterity, and the treatment’s potential cost-effectiveness.
Financial support for this large, academic-led trial of repurposed simvastatin, whose brand names include Zocor, comes from the U.K.’s MS Society, the National Institute for Health Research, the National MS Society (U.S), the British National Health Service (NHS) and participating U.K. and Irish universities.
“We are incredibly proud to be funding MS-STAT2, because we know what it could mean for people living with progressive MS. This condition is unpredictable, painful, and often exhausting, but finding an effective therapy means debilitating symptoms aren’t inevitable,” said Susan Kohlhaas, director of research at the MS Society.
“Today if you’re diagnosed with this form of MS you don’t have any options, but we’re getting closer to changing that, and hopefully delivering the solution everyone has been waiting for,” Kohlhaas added.
