Merck’s leukemia therapy Cladribine is also being tested as a treatment for relapsing-remitting multiple sclerosis (RRMS). Cladribine, marketed under the brand names Leustatin, Litak, and Movectro, works by selectively targeting lymphocytes, white blood cells believed to be linked with the development of MS.

Studies involving cladribine for RRMS

Cladribine has gone through several rounds of testing for RRMS. The results of the CLARITY Phase 3 clinical trial (NCT00213135), which involved more than 1,300 people with RRMS, were published in 2010. The study compared the effects of two doses of cladribine with a placebo. Both doses reduced patients’ relapse rate more than 50 percent. Results from an extension to the study (NCT00641537) showed that cladribine continued to limit relapses two years after it was administered.

Another Phase 3 clinical trial, ORACLE (NCT00725985), covered 616 participants. It showed that taking cladribine after an initial demyelinating event delayed the onset of MS. A demyelinating event is a show of symptoms resulting from deterioration of myelin, a protective nerve coating. Initial demyelination-event symptoms can include nerve pain, fatigue, loss of vision and bladder or bowel problems.

The Phase 3 ORACLE trial also showed that people who took cladribine tablets after their first demyelinating event significantly reduced the risk of their disease progressing to MS itself, compared with a placebo. Those who received cladribine during the clinical trial’s initial treatment phase ended up with lower annualized relapse rates than those who received a placebo during initial treatment.

The results prompted the European Medicines Agency (EMA) to agree to review the Marketing Authorization Application of cladribine for the treatment of RRMS.

MS patients who have participated in cladribine studies (NCT01013350) can have their names added to a register dealing with the drug’s safety until late 2018.

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