Print This Page Drug Being Studied In Clinical Trials May Control Spasticity Without Causing Drowsiness for People With Spinal Cord Injuries February 4, 2008 Media Contact: Jane Sanders (404-350-7707) The drug, called AV650 or tolperisone, has been used in Europe, Japan and South America collectively for more than 40 years and shows minimal sedation. Shepherd Center and up to 10 other sites – including ones in California, Missouri, Montana, New Jersey, North Carolina and Virginia – are now recruiting people who want to participate in tests of the drug’s safety and effectiveness. The drug is being developed by Avigen Inc., a biopharmaceutical company based in Alameda, Calif. “We need improved ways to treat patients with spasticity, especially those who are unresponsive to or cannot tolerate existing medications,” said Dr. David Apple, medical director emeritus at Shepherd Center. “Our hope with this study is to find a drug that is safe for patients and provides adequate symptom relief without causing harmful side effects.” The research study is enrolling up to 120 people nationwide with spinal cord injuries (SCI). Participants are being randomly assigned to receive the investigational drug (taken by mouth three times per day for 35 days) or a placebo (inactive substance). They must make eight study-related visits to the clinical trial site, and will receive a small stipend for their time and related expenses. The trial requires eight weeks, which includes a wash-out period for people currently taking spasticity medications. Spasticity is a common consequence of spinal cord injury. It occurs when the normal flow of nerve signals is interrupted below the level of injury, prompting an exaggeration of reflexes that can leave patients’ muscles jumping. AV650 may stabilize nerve membranes and restore upper motor neurons, inhibiting the reflex pathways that cause spasticity and spasms. “AV650 may offer significant advantages over current treatment regimens for spasticity,” said Glenn Morrison, Ph.D., associate director of clinical affairs at Avigen. “If AV650 proves to be non-sedating (in patients with SCI), it could lead to improved treatment and a better quality of life.” Uncontrolled muscle spasms can be painful and often interfere with patients’ ability to sit comfortably, maintain balance, get restful sleep and engage in daily activities, such as dressing or eating. “Sometimes when muscle spasms kick in, patients can’t move at all,” said physical therapist Michelle Nemeth, SCI Lead Clinical Research Coordinator at Shepherd. Such involuntary spasms pose safety concerns because patients can easily fall out of their wheelchairs or off the bed. Also, some people with spasticity experience difficulty breathing if spasms clamp down on their chest muscles. The constant muscle contractions and scraping of the skin increases the risk of pressure sores and subsequent skin breakdown, whether it’s from sliding against the sheets or hitting legs against a wheelchair, Nemeth added. Spasticity is treated with some currently available medications, but patients often experience side effects, especially drowsiness. “The challenge is to establish a better balance between managing the functional impairments of SCI and the adverse effects of these medications,” Dr. Apple said. “Certainly to throw a cognitive impairment on top of a physical one because of a drug is double jeopardy.” For more information about the AV650 study at Shepherd Center, please contact Carlyn Kappy at 404-367-1375 or carlyn_kappy@shepherd.org or Michelle Nemeth at 404-509-1003 or michelle_nemeth@shepherd.org. For additional information and to inquire about participating in the study at another location, see www.avigen.com or call 1-866-924-4695.
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