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Multi-National Clinical Trial Shows Effectiveness of Amantadine in Treatment of Traumatic Brain Injury
February 29, 2012
BOSTON (March 1, 2012) – A multi-national study published today in the New England Journal of Medicine revealed a significant breakthrough in the treatment of patients in vegetative and minimally conscious states. The study showed that the drug amantadine hydrochloride accelerated the pace of functional recovery during active treatment in patients with post-traumatic disorders of consciousness.
The study, funded by a 5-year, $3 million grant from the National Institute on Disability and Rehabilitation Research, involved 184 patients at 11 clinical trial sites in three countries. JFK Johnson Rehabilitation Institute in Edison, NJ and MossRehab in Philadelphia served as the lead centers for the international study. The patients involved were receiving inpatient rehabilitation and were in a vegetative or minimally conscious state between four and 16 weeks after traumatic brain injury. During the four week treatment period, recovery was significantly faster among patients who were administered amantadine than those in the placebo group.
Study leader, Joseph T. Giacino, Ph.D, who now serves as Director of Rehabilitation Neuropsychology at Spaulding Rehabilitation Hospital said, “The results of this study provide convincing evidence that it is possible to increase the speed of recovery from severe traumatic brain injury when treatment is initiated within four months of onset. These findings engender optimism for a medical condition that is often viewed as untreatable.”
The study results pave the way for additional studies of a drug whose therapeutic value was previously undetermined. “Now that we know that amantadine can accelerate neurologic recovery, we need to explore the dose and treatment schedule that provides the greatest and most durable treatment impact,” said study co-leader, John Whyte, M.D., Ph.D, Director of Moss Rehabilitation Research Institute. “Importantly, this study adds to the growing evidence that patients with disorders of consciousness have rehabilitation potential that we are just beginning to tap.”
In addition to JFK Johnson Rehabilitation Institute and MossRehab, nine other rehabilitation institutions participated in the study including Braintree Rehabilitation Hospital in Braintree, MA.; Bryn Mawr Rehabilitation Hospital in Malvern, PA; Carolinas Rehabilitation in Charlotte, NC; Fachkrankenhaus Neresheim Hospital in Neresheim, Germany; Copenhagen University Hospital in Glostrup, Denmark; Methodist Rehab Center in Jackson, MS; Schoen Klinik Bad Aibling in Bad Aibling, Germany; Sunnyview Rehabilitation Hospital in Schenectady, NY; and Texas Neurorehab Center in Austin, TX. In addition, the Department of Biostatistics in the Mailman School of Public Health at Columbia University in New York City served as the Data Coordinating Center under the direction of Emilia Bagiella, PhD.