8/5/10

Investigators Recruiting Globally For Phase II Study Of Oral Multiple Sclerosis Pill

(Posted By: Josi Creek)

Investigators are recruiting 400 people with relapsing-remitting MS for a study evaluating three doses of ACT-128800, an oral compound that affects immune function, versus placebo. The study sponsor is Actelion Pharmaceuticals, Ltd. 
Rationale: Multiple sclerosis involves an immune system attack on the brain and spinal cord. ACT-128800 binds to a docking site (sphingosine-1-phosphate receptor 1, or S1P1 receptor) on immune cells, including T cells and B cells (lymphocytes) that have been implicated in causing nervous system damage in MS. The once-a-day pill induces lymphocytes to remain in lymph nodes, where they can do little harm, preventing these cells from migrating into the brain and spinal cord. A similar drug, fingolimod (Novartis International AG) was recently recommended for U.S. FDA Approval by an FDA advisory committee, based on positive results from two large-scale phase III clinical trials. ACT-128800 is more selective for the S1P1 receptor.

Eligibility and Details:Participants may include individuals aged 18 to 55 with a diagnosis of relapsing-remitting MS. Patients with ongoing bacterial, viral, or fungal infection, or a history or presence of malignancy will be excluded. Additional criteria - including previous treatment or medical conditions that might exclude individuals from participating - can be obtained by contacting the study investigators via the email listed below.

Participants will be randomly assigned to receive one of three doses of ACT-128800 once daily for 24 weeks, or placebo. The primary outcome being measured is the effect of the drug on disease activity observed on MRI scans. Secondary outcomes being measured are ACT-128800's effect on relapse rate, time to first relapse, and safety/tolerability.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please email medinfo@actelion.com.

Sites are recruiting participants worldwide, and in the following U.S. cities:

Akron, OH Baltimore, MD Burlington, VT Cincinnati, OH Columbus, OH Indianapolis, IN Kansas City, KS Kirkland, WA Latham, NY New York, NY Newark, NJ Philadelphia, PA Portland, OR Raleigh, NC Richmond, VA Sacramento, CA Sarasota, FL Schenectady, NY Scottsdale, AZ Shawnee Mission, KS St. Louis, MO Stanford, CA Stony Brook, NY Tucson, AZ Worcester, MA

Labels: Research, Studies