Upstate News

July 26, 2000
Darryl Geddes 315 464-4828

SUNY Upstate is tapped to test new treatment for multiple sclerosis

SUNY Upstate Medical University has been selected as a site to launch a worldwide landmark study to investigate whether an oral treatment option might be available for people living with relapsing-remitting multiple sclerosis. Current treatment options involve regular injections with a needle. Many physicians feel that an oral therapy in the form of Copaxone would be a significant development in treating multiple sclerosis, citing that many people are uncomfortable self-injecting.

Titled “The Coral Study” it is the largest clinical study for people with multiple sclerosis, spanning five continents and 18 countries. It will involve 178 study sites around the world, 58 of which are in the United States, including Upstate Medical University in Syracuse.

The local effort will be spearheaded by Cornelia Mihai, M.D., assistant professor of neurology in the College of Medicine at SUNY Upstate Medical University and director of the Multiple Sclerosis Clinic at University Hospital. She will be joined in the study by Burk Jubelt, M.D., chair of the neurology department at University Hospital, and Michael Vertino, M.D., clinical assistant instructor of neurology at University Hospital.

According to Mihai, the Coral Study is a Phase III clinical study. Phase III studies follow years of extensive research and are often the final step before a request is made to the Food and Drug Administration (FDA) for approval to market a drug.

Recruiting study participants
“We are working with the medical community to identify people between the ages of 18 and 50, [inclusive] who have a confirmed diagnosis of relapsing- remitting multiple sclerosis. Locally, we will recruit at least 12 participants from the approximately 600 multiple sclerosis cases followed in University Hospital’s Multiple Sclerosis Clinic,” Mihai said. “Worldwide, researchers will recruit 1,300 participants, including 600 to 700 Americans. Our recruitment efforts should continue for at least six months or until the enrollment is completed.”

In addition to the above criteria, the study is open to people who:

  • have received a confirmed diagnosis of relapsing-remitting multiple sclerosis and who have been diagnosed for at least six months;
  • have at least one documented relapse within one year prior to study entry;
  • are relapse-free at least 30 days prior to screening;
  • are relapse-free during the screening period;
  • are able to swallow whole tablets; and,
  • who have a Expanded Disability Status Scale (EDSS) baseline of 0 to 5.0, inclusive.

Mihai said there are several factors that might exclude possible participants from the study, including previous use of Copaxone for injection. “We are encouraging interested individuals to speak with their physician or call University Hospital’s Multiple Sclerosis Clinic at 315-464-5356 regarding their possible participation,” she said.

The Coral Study is a randomized, double-blind placebo-controlled study. It will determine if an oral form of Copaxone (glatiramer acetate for injection) is safe and effective for the treatment of relapsing-remitting multiple sclerosis. The study will last 56 weeks. The primary goal of the study is to measure the total number of relapses observed during that time. The study will also measure the total number of relapses severe enough to require treatment with steroids; the progression of disability as measured by Expanded Disability Status Scale scores; the effects on cerebral MRI; the safety of an oral formulation of Copaxone; and the tolerability of an oral formulation of Copaxone.

Participants will be divided into one control and two treatment groups. The three arms of the study will compare daily doses of 50 mg of oral glatiramer acetate, 5 mg of oral glatiramer acetate, and oral placebo. All tablets are enteric-coated, to prevent stomach upset.

Copaxone is glatiramer acetate for injection. Development of the oral formulation of the medication began in 1996. Copaxone appears to block myelin specific autoimmune responses. Myelin is a protective coating that insulates nerves. In multiple sclerosis, it is thought that the immune system attacks myelin basic protein. Myelin is broken down, causing disruptions in the signals sent to and from the brain. The active ingredient of Copaxone, glatiramer acetate, consists of the acetate salts of synthetic polypeptides, which resemble the structure of myelin basic protein. While it is not known exactly how Copaxone works, it is believed to block myelin-damaging T cells. Treatment with Copaxone creates special T cells that are thought to cross the blood-brain barrier into the central nervous system. When they come into contact with myelin and other proteins in the central nervous system, they are believed to release helpful anti-inflammatory substances (cytokines) that reduce the inflammatory process, which can cause demyelination.

Individuals who are interested in learning more about the Coral Study are encouraged to contact their physician or call Health Connections at University Hospital at 800-464-8668 or 1-800-31CORAL.

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