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[December 19, 2012]
UNC program joins major autism study
CHAPEL HILL, Dec 19, 2012 (The Herald-Sun - McClatchy-Tribune Information Services via COMTEX) -- An autism research program at UNC is taking part in a global study to evaluate the impact of the investigational drug memantine on social interaction and communication in children with autism, Asperger's Disorder and Pervasive Developmental Disorder Not Otherwise Specified.
The university's Adolescent and School-age Psychiatric Intervention Research Program (ASPIRE) is partnering with the ConnectMe Clinical Research Program in the major study to evaluate the safety, tolerability and efficacy of the drug in children ages 6-12.
The U.S. Centers for Disease Control and Prevention estimate that one in 88 children in the United States is affected by autism, Asperger's or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
Memantine is used to treat adult patients with Alzheimer's disease.
No Federal Drug Administration (FDA)-approved drugs treat any of the core symptoms of autism, which are impaired social interactions, impaired communications, restricted interests, repetitive behaviors and stereotyped mannerisms.
"Right now we have treatments in autism that deal with mood swings and temper tantrums and kinds of irritability," said Linmarie Sikich, director of ASPIRE. "There are two drugs the FDA has approved for that, but we don't have any drug treatments that really target how they get along with people, how they interact with other people and that is at some level the crux of autism." Researchers have already begun to enroll patients in the study in Chapel Hill and in the other 80-plus sites throughout the U.S. and the rest of the world, and will continue the enrollment process for at least another year.
"We're really excited to be participating in this study that's really trying to address these core symptoms of autism," Sikich said. "We hope that we can help develop treatments that help more effectively with the problems that go along with autism." The ideal candidate is an autistic child who has some language skills, but no serious medical illnesses such as epilepsy, seizures or Tourette's syndrome, for example.
"The inclusion criteria are pretty open," Sikich said. "We do want to make sure they are having significant social impairments, which is usually part and parcel of having an autism spectrum disorder. That is the major exclusion criteria, that their social problems weren't severe enough." Sikich said Forest Research Institute Inc., the study's sponsor, is working with the FDA to determine exactly how many children need to be enrolled to conduct the study.
During the first phase of the study, Sikich said all children -- ASPIRE has the capacity to enroll 20 to 30 students -- will receive the drug for up to 48 weeks.
"What we're looking for is to see if over that period of time there will be at least 12 weeks when they are doing much better in terms of social interactions and how they relate to other people," Sikich said.
She said those children who reach that threshold will then move into the second phase of the study to determine if they need to continue to taking the medicine to maintain those social gains.
"Half of the people in that second study would continue getting the medicine and the other half would get a placebo or sugar pill and we would see if there was any difference between how those two groups of people did," Sikich said.
She said the second phase of the study will be critical in determining whether the drug is effective.
"It's the part of the study that will let us know if the medicine works for really improving those social gains," Sikich said.
ASPIRE has four children enrolled in the study and is scheduled to screen more children who could join the study.
If there is a demand for it, Sikich said she hopes the sponsor will allow more children to join the study than the 20 to 30 ASPIRE currently has the capacity to handle.
"If we're having good luck getting people in the study, then we hope that we can increase the capacity as needed," Sikich said. "I wouldn't foresee somebody needing to not be enrolled because we didn't have capacity." And how will the success of the study be determined "I think we will know whether this treatment helped children with autism make better friends, pick up social cues better, hold conversations, go back and forth better and basically be able to be in more normal, better relationships with the people around them," Sikich said.
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