MS Trial Alert: Investigators Recruiting 1,410 People with Relapsing MS For Study of Oral RPC1063 - National Multiple Sclerosis Society

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MS Trial Alert: Investigators Recruiting 1,410 People with Relapsing MS For Study of Oral RPC1063

September 16, 2013

Summary: Investigators worldwide are recruiting 1,410 people with relapsing MS for a study testing the safety and effectiveness of the experimental oral therapy RPC1063 (Receptos, Inc.) versus inactive placebo. The study is funded by Receptos, Inc.

Rationale: RPC1063 is a selective sphingosine 1-phosphate receptor modulator (similar to the mode of action of Gilenya™ (fingolimod, Novartis International AG) and is thought to act by retaining certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the central nervous system. In a phase 1 study in 88 people with MS, RPC1063 was generally well tolerated and had a significant effect on immune cell activity at doses ranging from .3 mg to 3 mg. Cardiac/pulmonary adverse events occurred in 5 people taking more than 1.5 mg, and resolved without medical intervention. (Abstract #P01.178, presented at the American Academy of Neurology Meeting in 2013)

Eligibility and Details: Participants should be aged 18 through 55, with a diagnosis of relapsing MS.  Individuals with significant pre-existing cardiac (heart) or pulmonary (lung) conditions are excluded. Further details on inclusion and exclusion criteria are available from the contact below.

Participants will be randomly assigned to one of two groups. In one group of 210 participants, people will be randomly assigned to take oral RPC1063 (.5 mg), RPC1063 (1 mg), or placebo. In another group of 1200 participants, people will take oral RPC1063 (.5 mg), RPC1063 (1 mg), or Avonex (30 mcg/wk) injected into muscle.

The primary outcome being measured by this study is new or enlarging disease activity as observed on MRI scans. Secondary outcomes include time to sustained disease progression, and changes in the MS Functional Composite (a measure of disease progression), visual function, brain tissue volume loss, and quality of life. Participants are being closely monitored during initial dose administration and during regular assessments throughout the study for effects on cardiovascular and pulmonary function.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visit the study website at or call Jeff Hartung, Receptos at (858) 652-5736. 

Sites are going to be recruiting in the following cities:

  • Akron, OH
  • Berkeley, CA
  • Charlotte, NC
  • Cleveland, OH
  • Fresno, CA
  • Maitland, FL
  • Philadelphia, PA
  • Phoeniz, AZ
  • Raleigh, NC
  • Sacramento, CA
  • Seattle , WA
  • Weston, FL

Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).

About Multiple Sclerosis

Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.