Nov 05, 2009
MS Trial Alert: Recruiting Nationwide for Study of Copaxone in Patients with First Episode of Acute Optic Neuritis
Summary: Investigators at sites throughout the United States are recruiting 200 people who have experienced one episode of acute optic neuritis, to determine whether nerve fiber loss can be minimized with administration of glatirmamer acetate (Teva Pharmaceutical Industries) treatment. Optic neuritis is an inflammation of the optic nerve, and often is the first symptom of multiple sclerosis. The study is funded by Teva Pharmaceutical Industries.
Rationale: Glatiramer acetate is a synthetic protein that simulates myelin basic protein, a component of the myelin sheath that insulates nerve fibers in the brain and spinal cord.This drug seems to block myelin-damaging T-cells through a mechanism that is not completely understood. Glatiramer acetate is approved by the U.S. Food and Drug Administration to treat patients with relapsing-remitting MS and individuals who have experienced a first clinical episode (clinically-isolated syndrome) and have MRI features that are consistent with MS.
In animal models, glatiramer acetate has shown some ability to reduce nerve fiber loss. In the current study, investigators are studying whether the drug can protect against thinning of the optic nerve (indicative of nerve fiber degeneration) in people who experience a first episode of optic neuritis. Often, these people go on to develop MS.
Eligibility and Details: Participants will be aged 18 to 45, and will have experienced first episode of acute optic neuritis. Participants must be enrolled in the study no more than 9 days after the onset of visual disturbance. A diagnosis of MS will exclude people from participating in this study.
Participants will receive either glatiramer acetate (20 mg) or placebo daily delivered via injection under the skin) for six months. The primary endpoint is to compare changes in retinal nerve fiber layer thickness. Secondary endpoints include measures of visual function.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visit http://www.tevaclinicaltrials.com/Acute-Optic-Neuritis/default.aspx. Sites are located in the following cities:
Durham, NC
Atlanta, GA
Baltimore, MD (2 sites)
St. Petersburg, FL
Berkeley, CA
Richmond, VA
Rochester, NY
Newark, NJ
Seattle, WA
Peoria, IL
Charlotte, NC
New York, NY
New Brunswick, NJ
Tallahassee, FL
Syracuse, NY
Buffalo, NY
Fort Collins, CO
Oklahoma City, OK
Glenview, IL
Philadelphia, PA
La Jolla, CA
Charlottesvile, VA
Missoula, MT
Salt Lake City, UT
Minneapolis, MN
Miami, FL
Pompano Beach, FL
Albany, NY
Aurora, CO
Grand Rapids, MI
Golden Valley, MN
Houston, TX
St. Louis, MO
Prairie Village, KS
Milwaukee, WI