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Clinical Trials for Children with Seizures and Epilepsy

A new federal ruling allows children to participate in medical research, including seizures and epilepsy clinical trials.

By Katherine Lee

Medically Reviewed by Pat F. Bass III, MD, MPH

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Doctors are working to find new treatments for children with seizure disorders and epilepsy. In most cases, research is conducted through clinical trials, where researchers investigate the safety and effectiveness of a new treatment. Until recently, children were not allowed to participate in clinical trials. But, a new law allows researchers to test the safety and effectiveness of a treatment in children. This can have a major impact on the way childhood illnesses are treated, including seizures and epilelpsy treatments.

Seizures and Epilepsy: Clinical Trials and Children

“In general, most epilepsy medications and treatments were tried only in adults to prevent putting kids at risk,” says Mohamad Mikati, MD, professor of pediatrics and neurobiology and chief of the division of pediatric neurology at Duke University Medical Center, in Durham, N.C. “That was a noble goal, but the problem became that none of these drugs were studied in children and nobody knew whether or not they worked for kids.”

Without adequate testing in children, doctors were left to guess how to best prescribe medication to children. “Where there was no information or only a little bit of data on a particular medication, we’d have to say, ‘I don’t think it’ll make it worse and it could work based upon adult or animal lab studies,’” says John M. Pellock, MD, professor and chairman of the division of child neurology at Virginia Commonwealth University, in Richmond.

A few years ago, the U.S. Food and Drug Administration (FDA), which has federal oversight of clinical trials, changed the rules. “Now, any new drug, such as for epilepsy, must have a plan in place to do trials in children,” says Dr. Pellock. However, drugs that are primarily designed for diseases that begin in childhood, such as Lennox-Gastaut Syndrome, are not required to have adult trials first.

That FDA ruling has cleared the way for better treatment for children with seizure disorders. “The more drugs we have, the more options we have to control seizures,” says Blaise Bourgeois, MD, director of the division of epilepsy and clinical neurophysiology at Children’s Hospital Boston.

Seizures and Epilepsy: Latest Research

The following studies are ongoing in hopes of finding new ways to treat seizures and epilepsy:

  • Deep-brain stimulation.Currently being tested in adults, deep brain stimulation involves a detection system that, as a seizure begins, will trigger another electrical stimulation of other areas in the brain to stop the seizure or reduce its severity.
  • Direct delivery of neurotransmitters.This research, currently involving lab animals, is testing the delivery of neurotransmitters directly into the areas of the brain where seizures take place. If proven safe and effective, this technique could mean that children with seizures and epilepsy may no longer have to take medication, thus avoiding problems associated with regular medicine use, such as liver toxicity.

Seizures and Epilepsy: Finding Clinical Trials for Children

To learn more about clinical trials for children with seizures and epilepsy:

  • Call your local medical center.Or talk to your doctor. Many major medical centers have epilepsy programs. This is often a great option since many clinical trials involve frequent visits to the medical center for tests and monitoring.
  • Contact national epilepsy groups.Often, these groups have the latest on ongoing trials for epilepsy. Try the Epilepsy Foundation, Epilepsy.com, or the American Epilepsy Society.
  • Check out. This is the National Institute of Health's website for information on national and international clinical trials.

Whether your child’s epilepsy is a benign type that your child will most likely outgrow, such as those caused by a genetics, or a more serious form that’s characterized by severe seizures, improved treatment can help you and your family manage the condition and improve your child's long term outlook.






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Date: 08.12.2018, 04:33 / Views: 62482