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Study to Compare the Efficacy and Safety of Fingolimod with Glatiramer Acetate

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Recurring Event
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In Person

A 12-month, randomized, rater- and dose-blinded study to compare the efficacy and safety of fingolimod 0.25 mg and 0.5 mg administered orally once daily with glatiramer acetate 20 mg administered subcutaneously once daily in patients with relapsing-remitting multiple sclerosis.

Recruitment period

  • Open until full

Location of study/trial

  • Virginia Mason MS Center, Seattle, WA

Recruiting

  • The main purpose of this study is to compare 2 doses of fingolimod (0.25 mg and 0.5 mg) with glatiramer acetate 20 mg and to evaluate the effectiveness and safety of fingolimod 0.25 mg for people with RRMS.
  • Male and female patients 18 to 65 years of age, inclusive
  • Patients with RRMS, as defined by 2010 revised McDonald criteria
  • Patients must be neurologically stable with no onset of relapse or any steroid use within 30 days of randomization
  • Patients with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years before randomization
  • Patients with an EDSS score of 0 to 6 inclusive at Screening. A score of 6.0 indicates unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting
     

Principal investigator

  • Mariko Kita, MD

 

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Contact information

Suzanne Vogt
suzanne.vogt@vmmc.org
206-342-6514


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