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news.Serono has begun enrolling patients in the US into a phase III trial of oral cladribine for the treatment of patients with relapsing forms of multiple sclerosis.
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This multi-national study was successfully initiated outside the US in 2005, and will now expand to include 17 clinical trial sites in the US. The study is one of the largest MS trials ever conducted, and enrollment is on track to be completed in 2006.
The two year trial, in more than 1,200 patients, is designed to assess patients’ clinical relapses, disability progression and MRI (magnetic resonance imaging) brain activity.
Previous clinical trials using cladribine administered by injection in patients with MS showed positive effects in reduction of new lesion development in the brain as seen on MRI scans; reductions in relapses were also observed.
“The addition of US sites will accelerate this pace and bring us one step closer to our goal of making the first oral MS therapy available for people living with this debilitating condition, underscoring our fundamental and long-term commitment to the MS community,” said Dr Paul Lammers, chief medical officer at Serono.