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Cannabis-derived treatment shows significant seizure reduction in Nationwide Children's study

COLUMBUS (WCMH) - Children and adults with a severe and complex form of epilepsy called Lennox-Gastaut Syndrome can have hundreds of seizures each day. 
 
A cannabis-derived treatment studied at Nationwide Children's Hospital is showing impressive results in reducing those seizures, bringing hope to families. It’s a part of an international study, with 30 centers participating in the U.S. and Europe. 
 
"Marissa started smiling again with the medication," said Ronda Parsons. "She’s herself now. She’s back to where she was before all of these seizures took their toll on her.”
 
Ronda's 21-year-old daughter, Marissa Parsons, suffers from Lennox-Gastaut Syndrome. 
 
“She would literally wake up and just seize and seize and seize," said Ronda. 
 
As a baby, Marissa experienced 50-100 seizures per day. 
 
“They’re holding their breath and you can’t get them to breathe. It’s like everything has shut down in their brain and they’re seizing," said Ronda. “It was scary. She was my first child, so it was very scary with not knowing what to expect.”
 
After trying several different kinds of medication and treatment over the years, nothing seemed to control Marissa's seizures. 
 
“What would happen is we would try the medicine and it would work for a little while or a side effect would happen," said Ronda. “One of the drugs she was on caused pancreatitis and she got very, very ill when she was two-years-old and I wasn’t sure we were going to bring her home.”
 
Marissa was having 5-8 seizures a day before she was enrolled in the cannabidiol clinical trial at Nationwide Children's Hospital. Her mother said 2-3 times per month they were using emergency medication and sometimes Marissa would end up at the hospital.
 
“Now with only having only one or none a day, we’re over the moon with it," said Ronda. 
 
Dr. Anup Patel is a primary investigator for the trial and co-first author for the double-blind, placebo-controlled study that was released in the New England Journal of Medicine on Wednesday.
 
“We looked at using a plant-based, liquid formulation of cannabidiol, which is derived from the base plant, marijuana," he said. "The part of the plant that we worry about, the part that gets you high, the part that can affect a developing adolescent or child’s brain from not growing, that’s removed."
 
He said patients with Lennox-Gastaut are often treatment resistant, meaning they only have a 1% chance of ever becoming seizure-free.
 
During the trial, Dr. Patel said patients in the higher dosing range saw a 42% median seizure reduction, compared to a 17% reduction to those on a placebo.
 
“We really just struggle to be able to find treatments that work for them, so anything that we can do to help that population or even other similar populations is pretty exciting," said Dr. Patel.
 
 
He said about 90% of patients experienced side-effects, not any more or any less that’s typically seen in clinical trials. Dr. Patel said tiredness was the most commonly seen side-effect, as well as vomiting and nausea. 
 

During the trial, Dr. Patel said patients in the higher dosing range saw a 42% median seizure reduction, compared to a 17% reduction to those on a placebo.

 
He said the goal of the study is to help a pharmaceutical company get an FDA approved medication.
 
"If they’re successful and we hope that this trial has helped that cause and we had a major part of that at Nationwide Children Hospital, it will lead to the first plant-based marijuana product FDA-approved in the history of our country for any disease state and that’s a pretty amazing accomplishment," said Dr. Patel.
 
Dr. Patel said the FDA is expected to make a decision on whether to approve the medicine by late June. Then, the DEA has 90 days to reschedule the drug, cannabidiol. 
 
“If you were to get an FDA approved product through this process, you don’t need a state law to be changed. You don’t need regulations to be put in place," he said. "Anybody with an active medical license can prescribe this for their kids who have seizures or adults who have seizures."
 
He's hopeful it leads to other kids getting better because of this research. 
 
“To be able to offer a treatment that might work for more than one type of seizure is really encouraging because then it allow us to potentially not having to use many different treatments and then we can minimize the number of medicines that kids are on," said Dr. Patel. 
 
Already, Marissa is seeing the benefits. 
 
"We went out to the Grand Canyon two years ago and that was something I would have never imagined doing just because of the fear of her having a really bad seizure and having to be hospitalized away from home," said Ronda. “It’s changed my life, her life, her sisters, her dad, all of our lives.”

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