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Investigators Recruiting for Study of ALKS 8700 vs. Dimethyl Fumarate in Relapsing-Remitting MS

August 18, 2017

SUMMARY
Investigators are recruiting 420 people with relapsing-remitting MS for a phase 3 study comparing gastrointestinal side effects experienced during treatment with oral ALKS 8700 (Alkermes, Inc.) or Tecfidera® (dimethyl fumarate, Biogen, Inc.). The study is funded by Alkermes, Inc.
 
DETAILS
Rationale: Multiple sclerosis occurs when the immune system mistakenly attacks nerve fiber-insulating myelin and other brain and spinal cord tissues. Although its exact mechanism of action is not known, oral dimethyl fumarate, which is approved to treat people with relapsing MS, is thought to inhibit immune cells and molecules and may be protective against damage to the central nervous system. Gastrointestinal events (such as diarrhea, nausea, and upper abdominal pain) can occur in people taking dimethyl fumarate.
 
ALKS 8700 is an oral monomethyl fumarate, a similar compound to dimethyl fumarate. This study is seeking to determine whether treatment with ALKS 8700 results in fewer gastrointestinal side effects than treatment with dimethyl fumarate. A second phase 3 study testing the safety of ALKS 8700 treatment is ongoing in 935 people with relapsing-remitting MS.
 
Eligibility and Details: Participants should be from age 18 to 65, and diagnosed with relapsing-remitting MS. Prior treatment with dimethyl fumarate is not permitted. Further enrollment criteria are available from the contact below.
 
Participants will be randomly assigned to receive either ALKS 8700 or dimethyl fumarate twice daily via oral capsules for 5 weeks. The total study participation is approximately 11 weeks. The primary outcome being measured is the number of days that participants experience gastrointestinal side effects. Secondary outcomes include other measures of gastrointestinal side effects, and the incidence of other side effects. Eligible participants who complete the study may elect to roll over into the phase 3 long-term safety study of ALKS 8700 which lasts approximately two years.
 
Contact: For more information, please contact Emily Rebecca Moore, by phone: 512-904-4325, or email: EmilyRebecca.Moore@INCResearch.com. Sites are recruiting in the following cities in the United States:
Albuquerque, NM
Alexandria, LA
Atlanta, GA
Atlantis, FL
Basalt, CO
Berkeley, CA
Bradenton, FL
Canton, OH
Centennial, CO
Charleston, SC
Charlotte, NC
Columbus, GA
Columbus, OH
Cullman, AL
Dallas, TX
Dayton, OH
Denver, CO
Des Moines, IA
Detroit, MI
Evanston, IL
Franklin, TN
Golden Valley, MN
Greensboro, NC
Greer, SC
Houston, TX
Indian Land, SC
Knoxville, TN
Lenexa, KS
Long Beach, CA
Maitland, FL
Middlebury, CT
Naples, FL
Newport News, VA
Oklahoma City, OK
Ormond Beach, FL
Patchogue, NY
Phoenix, AZ
Providence, RI
Raleigh, NC
Richmond, VA
San Diego, CA
Sarasota, FL
Seattle, WA
Spartanburg, SC
St. Louis, MO
Stamford, CT
Stony Brook, NY
Syracuse, NY
Tampa, FL
Tucson, AZ
Vero Beach, FL
Washington DC
Winston-Salem, NC
 
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
 
Without participants in research studies, MS research would come to a standstill. Read more here.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts 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 leading to better understanding and 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.

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