WEDNESDAY, Feb. 29 (HealthDay News) -- A drug that's typically
used to treat the flu and Parkinson's disease appears to speed
recovery in traumatic brain injury patients, a new study
Traumatic brain injury (TBI) victims who weren't fully conscious
and were discharged to rehabilitation facilities after
hospitalization were given amantadine hydrochloride. The drug is
already given "off-label" to such patients, but if and how much it
helps has remained unclear.
While taking the drug, the patients given amantadine scored
better on behavioral tests that measure how well the brain is
functioning compared to a group of patients given a placebo,
researchers report in the March 1 issue of
The New England Journal of Medicine.
"Amantadine appeared to increase the rate of recovery compared to placebo. Patients got better faster while they were on the drug," said study co-author Joseph Giacino, director of rehabilitation neuropsychology at the Spaulding Rehabilitation Hospital, in Boston, and an associate professor in the department of physical medicine and rehabilitation at Harvard Medical School.
Study co-author Dr. John Whyte, director of the Moss
Rehabilitation Research Institute at Albert Einstein Healthcare
Network, in the Philadelphia area, said previous observational
studies had suggested amantadine improved the rate of recovery.
While the medicine is already commonly prescribed off-label to
treat people suffering from prolonged disorders of consciousness,
he said this is the first placebo-controlled trial of the drug in
patients who were either in a vegetative state (wakeful but not
aware) or a minimally conscious state (able to track with their
"There were many hypotheses out there about what this drug should do, but there was very little data to support or refute those hypotheses," Whyte explained.
For the study, 184 patients from 11 medical centers in three
countries were enrolled. They had all suffered a TBI within the
previous one to four months. Half received amantadine while the
other half were given a placebo for the first four weeks of the
six-week study. Both groups were followed up for two additional
weeks, Whyte said.
The researchers used the Disability Rating Scale (DRS) to
monitor patients' progress during the treatment and follow-up
period. The test measures eye opening, verbal ability and motor
response, among other functions, Giacino said.
"During the four-week treatment period, recovery was significantly faster in the amantadine group than the placebo group," said Giacino.
Whyte said during his 25-year career as a brain trauma
rehabilitation physician there have been no groundbreaking
treatments for these patients. TBI rehabilitation can take months,
or years, and many patients do not have the health insurance or
private funds to access good rehabilitative care, so a drug that
could speed recovery would be a boon, he said.
The ability of patients in a vegetative state or those in the
MCS "to access rehab has gotten less and less," Whyte said. "Many
of these patients go straight to a nursing home or home with
family." He noted that TBI remains the most common cause of death
and disability in people between the ages of 15 and 30.
The new finding "is very exciting because we have a new tool to
help improve these patients in their early outcome," said one
expert, Dr. J. Javier Provencio, director of the Neurocritical Care
Fellowship Program at the Cerebrovascular Center of the Cleveland
Clinic Neurological Institute.
"The take-home message is that this medicine is promising for patients in a very certain setting. I think the results have to be taken very strictly and not extrapolated to other conditions," said Provencio.
He noted that the rate of improvement in the drug group slowed
in weeks five and six. By the study's end, the overall improvement
from baseline between the placebo group and the amantadine group
That means that, "it is still unclear whether the effects last,"
Provencio said. "In the study, by week six, the effect difference
was getting smaller. I hope they follow these patients out to a
year to see how they do."
Study co-author Giacino said they were surprised when they saw
an immediate leveling off between the two groups in the final two
"But when I take a step back, it is even stronger evidence that this drug was doing something," he added.
Neurologist Dr. Daniel Labovitz, of Montefiore Medical Center in
New York City, believes hope should remain in check despite the
promising results. "It's not a home run. It's a small change and it
was temporary, and I think that would be the message that has to
Labovitz said the drug appears to be gently waking the patients.
"If this trial holds up in larger, longer-term studies, maybe you
can enhance the ability of [rehabilitation] therapists to interact
with patients while they're on the drug."
Giacino said the researchers also aimed to look at side effects
"There was not a single category where the amantadine group had a higher rate of side effects than the placebo group," he said.
Whyte said that while this research may influence more
rehabilitation experts to use amantadine for this type of patient,
more challenges remain before the drug's impact is completely
"This study isn't the end of the story," Whyte said.
For more on traumatic brain injury, head to the
U.S. National Institute of Neurological Disorders and
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