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Trial Shows Promise in Epileptic Children – WHAG News

WINCHESTER, Va. – When someone mentions marijuana, most might think of getting stoned – smoking or ingesting the plant for its tetrahydrocannabinol, or THC, the main psychoactive ingredient that gets you high.

According to an epileptic specialist in Winchester, this societal stigma is exactly why legalizing medical marijuana has been an uphill climb.

“The biggest misconception about medical marijuana is the confusion the public has about what it is,” said Dr. Paul Lyons, an adult and pediatric epileptologist with Winchester Neurological Consultants. “People think medical marijuana has psychocactive properties.”

Lyons had heard of using medical marijuana to treat epilepsy, but he wasn’t inspired to start researching until numerous parents started reaching out to him. He spent 13 months seeking approval from the Food and Drug Administration, along with numerous other federal and state agencies, before he was granted a license to administer oil-based medical marijuana.

There’s a clear difference, however, between Lyons’ marijuana and the kind that gets a person high.

“What I’m using is a purified, pharmaceutical grade extract of a plant,” Lyons said, “just as we do with other drugs.”

Epidiolex, the official name of Lyons’ liquid medical marijuana, is made of pure canabidiol (CBD), which is derived directly from the cannabis plant.

According to GW Pharmaceuticals, the United Kingdom-based company sponsoring the trial and manufacturing of the drug, Epidiolex is the first of it’s kind to contain no THC. GW Pharmaceuticals said it is the only company in the world that produces pharmaceutical grade pure plant-derived CBD, which can be administered orally as a suspension or via a feeding tube.

Lyons said while the pleas of many parents encouraged him to begin his research, it is their children, his patients, that kept him going.

“I believe that disease, particularly in children, is unfair,” Lyons said. “[Childhood is] a time when we should be burden-free, and able to explore our identity. All those normal developmental milestones of how to make friends, how to resolve fights, how to have sleepovers and how to play on a sports team – they’re deprived of those opportunities.”

Courtney Iser, a nine-year-old girl from Gore, Va., who’s suffered from epilepsy since she was six months old, is one of Lyons’ patients.

“You have to always monitor her,” said her mother, Sherri. “She can’t even be in another room by herself to play.”

Sherri and her husband David have tried everything they could think of to help with Courtney’s seizures, which have lasted as long as an hour. Courtney tried 12 different medications, a specialized diet for two years and even underwent physical surgery.

“The surgery helped bring her seizures down to one, maybe two minutes,” Sherri said. “But she still suffers constantly.”

It wasn’t until Sherri and David exhausted their options that they even began to think about medical marijuana.

“I started doing research on it, and realized that it’s extracted out of the plant into an oil, and that she wouldn’t be smoking it,” Sherri said.

Under his newly acquired license, Lyons has been able to prescribe Epidiolex to Courtney for the last two months. The oil is administered to Courtney through a syringe, by placing drops underneath her tongue twice a day.

Since starting Epidiolex, Courtney has had 23 seizure-free days, seven of which were consecutive. She is more alert, and active.

“I am an advocate for medical marijuana,” Sherri said. “Courtney is my number one, but if I can help other children out there, I would like to see all children seizure-free.”

Courtney’s results so far are good news to Lyons.

“Medical marijuana isn’t a cure, but it would give us another option in treating all types of patients with all kinds of epilepsy,” he said.

If statistics like this continue in trial patients, Lyons believes he has witnessed just the beginning of the legalization of medical marijuana in Virginia.

“I feel like there is strong evidence to suggest that medical marijuana will be legal in the state of Virginia, in my lifetime as a practicing physician.”

The medical marijuana trial is open to children who have a parent or guardian who can make it to Winchester Neurological Consultants for regular appointments. To find out more about the medical marijuana trial, and whether or not you qualify, you can call their office at 866-948-7055.

Retrieved from:http://www.your4state.com/story/d/story/medical-marijuana-trial-shows-promise-in-epileptic/21929/TC-QsCXJkkSsG_sodNLgVg

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Epilepsy Study Using Cannabinoids Shows Encouraging Signs

WINCHESTER — The results of an epilepsy study being conducted in Winchester have not been confirmed yet, but the signs have been encouraging.

So far, epilepsy medication Epidiolex, a controlled substance because it’s derived from the cannabis plant, has had a welcome effect on program participants, said Dr. Paul Lyons, medical director of the Virginia Comprehensive Epilepsy Program and attending physician at Winchester Medical Center.

“Overall it’s been terribly well tolerated,” Lyons said. “At the end of the day, the children have more seizure-free days, meaningfully, and the seizures they’re having are shorter.”

The three-month compassionate use study on two Virginia children with treatment-resistant, catastrophic forms of epilepsy is an unfunded, pro-bono effort by Lyons and Jennifer Stanford, a registered nurse and director of the Valley Health Clinical Research Department.

It started in November and monitors the effect of Epidiolex on treatment regimens the children were already following, Stanford said.

Epidiolex, dispensed by GW Pharmaceuticals in the United Kingdom, is the first drug approved by the Federal Drug Administration for medical research in epilepsy, Lyons said Wednesday at a news conference held at his office in Winchester Neurological Consultants.

It’s highly regulated because, as a derivative of the same plant that produces the psychoactive ingredient tetrahydrocannabinol (THC) in marijuana, it’s illegal for undocumented use in the United States.

“The big misperception of medical marijuana is the confusion the public has about what it is,” Lyons said. The drug he administers for the study is purified medical grade extract from the cannabis plant.

Patients in the study take the medication like they would cough syrup, Lyons said.

Side effects he mentioned are an upset stomach that can be alleviated by changing the dosage, and improved alertness.

Both participants — 9-year-old Courtney Iser, of Gore, and 12-year-old Caleb Thomas, of Virginia Beach — experienced mild stomach pain, but Lyons said neither had any other adverse response.

In fact, their parents have seen improvements.

Courtney, diagnosed with a severe form of epilepsy called Lennox-Gastaut syndrome, had her first seizure when she was 6 months old and was diagnosed, her mother Sherri Iser said. Courtney has tried 12 separate pharmaceutical medications; the high-fat, low-carb ketogenic diet used primarily for treating refractory epilepsy; and vagus nerve stimulation, which sends mild pulses of electrical energy to the brain via the vagus nerve.

“And with all that she still continues to have seizures,” Iser said.

Tracie Thomas’ son Caleb has experienced seizures since he was 3 and contracted viral encephalitis — an inflammation of the brain caused by virus.

He has tried all 24 anti-convulsive medications used for treating epilepsy, some more than once. He’s also tried the ketogenic diet and vagus nerve stimulation.

Since starting the Epidiolex study, Courtney and Caleb have both improved.

“He’s more alert, more engaged,” Thomas said. “… You can see a difference in his eyes, like he’s alive.”

“[Courtney] has had 23 seizure-free days of the 63 days we’ve been in the study,” Iser said. “Seven days have been consecutive.”

On Wednesday, moments before the news conference, Courtney had a seizure lasting a couple minutes. Her father said the seizure was much shorter than ones she had before beginning the study — some lasting hours and requiring emergency room treatment.

But Lyons is confident Epidiolex will have needed effects on the study of epilepsy — a condition the medical field has labored with for 102 years.

The need for better treatment of epilepsy inspired him to endure 13 months of phone calls, background checks and certifications to legally be able to possess and administer Epidiolex.

Classified a Schedule 1 controlled substance, it’s stored alone in a 500-pound safe that only Lyons can access.

Though the compassionate use study ends in another month, he said GW Pharmaceuticals has agreed to supply Courtney and Caleb with a year’s amount of Epidiolex free of charge, as Lyons monitors their conditions.

He also plans a fully funded study for treating patients of all ages with Dravet syndrome and Lennox-Gastaut syndrome, beginning in March or April and allows for more participants.

The randomized, placebo-controlled study will administer Epidiolex to half of study participants and a medically ineffective pill to the others.

After completing the study, he said all participants will be considered for access to Epidiolex.

Though other studies of Epidiolex are happening in New York, Chicago and San Francisco, Lyons’ office in Winchester is the only location in Virginia and the surrounding states certified to administer Epidiolex.

He said he hopes to also extend the study to his other offices in Purcellville and Charlottesville.

“If you can drive here, fly here, come here,” Lyons said.

To be considered for inclusion in the randomized study, contact Lyons at 866-948-7055 or at http://www.winchesterneurological.com, or Jennifer Stanford at 540-536-8978.

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For boy with epilepsy, marijuana oil could be key

VIRGINIA BEACH

Caleb Thomas’ seizures are sometimes just blank stares that pass in seconds.

Other times, they erupt in full-body spasms that cycle in and out for more than a day, one after another in clusters so tight the 11-year-old must go to the hospital to make them stop.

His mother, Tracie Thomas, said they’ve tried dozens of treatments in the decade since his diagnosis of epilepsy: A medical implant that stimulates the brain. A high-fat, low-carb diet that can stem seizures. Dozens of medications, some with side effects.

Still, the seizures continue, tormenting not only Caleb, but his mother and his 16-year-old brother, Austin, who has helped care for him since the boys’ father died in October.

Recently Thomas turned to yet another treatment, this one a little more controversial since it’s illegal to sell in Virginia: marijuana oil.

A growing number of families with epileptic children are doing the same. At least two Virginia families moved in the past year to Colorado, where marijuana is legal. A wave of states have changed laws to increase access to the oil.

In Virginia, it’s illegal to sell, and federal statutes prevent doctors from prescribing it. But Winchester neurologist Paul Lyons recently received clearance from the federal Food and Drug Administration to treat Caleb and two other Virginia patients with the marijuana extract called cannabidiol, or CBD, in a small study that could start within weeks.

Two groups are pushing for more access to medical marijuana oil. Lt. Gov. Ralph Northam, a Democrat, has met with members of Virginia Parents for Medical Marijuana and the Epilepsy Foundation of Virginia, and is working with legislative services to craft a bill for the next General Assembly session that could help children with epilepsy have more access to CBD.

The oil, given orally with a syringe, doesn’t have the psychoactive ingredient that creates the intoxicating “high” of smoked marijuana, earning it the nickname “Hippies’ Disappointment.”

Because of legal issues, no large, controlled studies have been done on the oil. Some anecdotal evidence, though, shows promise of an anticonvulsant effect.

“What we need are large, well-controlled research studies,” said Lyons, an advisory board member of the Epilepsy Foundation of Virginia. “But some of these kids don’t have time. You get one crack at being 6. One crack at being 10. I’m trying to balance addressing families’ desperation with compassion and doing something in a productive, measurable, scientific way.”

The Thomas family is hoping for relief from seizures that began after Caleb had a fever when he was 2 and the family was living in West Virginia.

At first, doctors thought it was a harmless virus. But one morning, his parents found him unconscious in bed. He went by ambulance to a hospital in Northern Virginia, where he stayed for a month, turning 3 in the intensive care unit.

He was diagnosed with epilepsy, which doctors believe was caused by viral encephalitis. While in the hospital, he had 50 to 60 seizures a day. Various medications reduced that number to the point where he could go home.

At first, he’d have a seizure about every month. Six months later, the number started creeping up.

The seizures went from one every couple of weeks to one a week. During the past four years, he’s had eight to 10 a day.

The family moved to Virginia Beach seven years ago, and he began receiving treatment at Children’s Hospital of The King’s Daughters in Norfolk. Dr. L. Matthew Frank, a neurologist who practices at CHKD and treats Caleb, said his seizures are some of the worst he has seen, falling in a category of children with what’s called “intractable” epilepsy.

In 2010, Caleb went to CHKD to have a vagus nerve stimulator implanted. Sometimes called a pacemaker for the brain, the device is placed under the skin in the chest area, with wires that run to the vagus nerve in the neck. It stimulates Caleb’s brain for 22 seconds, and then goes off for a minute, then back on.

He also has been to Johns Hopkins Hospital in Baltimore, where he tried the high-fat, low-carb ketogenic diet, which stems epileptic seizures in some people. In Caleb, the diet worsened them.

Doctors there also tested his brain to see whether the seizures were coming from one spot that could be surgically treated. What they found, though, was that the seizures were coming from both sides of the brain and also presented differently, so he was not a candidate for that treatment.

That’s when Thomas turned to the marijuana oil option. Frank told her that he wasn’t able to prescribe it and that scientific studies supporting its effectiveness still had not been done.

She reached out to the Epilepsy Foundation of Virginia, who told her about Lyons.

Lyons started exploring the treatment about a year and a half ago, when the mother of a child with severe seizures asked what he knew about using marijuana extract to control them.

He knew nothing. A few weeks later, another parent asked the same question. Then another.

“I believed it was incumbent on me to educate myself,” Lyons said.

What he discovered was that there were no large, controlled studies, but there was some anecdotal evidence that it helped in some cases. A company called GW Pharmaceuticals was producing a highly purified form of CBD under the name of Epidiolex.

The FDA has approved it for use in two studies, at New York University and the University of California.

Lyons reached out to the FDA, which informed him of the steps he needs to take to treat patients in an investigative study. He must get approval from the drug company, find an approved lab and pharmacy for testing and dispensing the oil, get a license from the Drug Enforcement Agency to administer the drug, and provide the FDA with his study protocols and results.

He hopes to start within a month or so. Because there will be so few participants in the study, it won’t have the weight of a more controlled study, but it could help some of the children involved and provide direction for investigators of larger trials. He said in some cases, CBD worsens the condition, so there’s risk involved – but that’s true of approved treatments as well.

Northam, a pediatric neurologist, said the legislation he wants approved would allow children with Dravet syndrome, a particularly severe type of epilepsy, greater access to CBD.

Del. Bob Marshall, R-Prince William County, has already let it be known that he’s against the idea. He questions loosening the law for a treatment that hasn’t been adequately tested for safety and effectiveness:

“There are regulatory processes to get drugs approved for a therapeutic purpose, and they should follow those.”

U.S. Rep. Morgan Griffith, R-9th District, also has introduced a bill in Congress to move marijuana from a Schedule I drug to Schedule II, which would make it easier for Virginia doctors to prescribe it.

Although Frank told the Thomas family he could not prescribe the marijuana oil, he said he supports Thomas’ efforts to try it under Lyons’ care, given the severity of Caleb’s seizures.

Caleb takes 20 pills a day now, causing side effects that range from fatigue to aggression. He’s missed a lot of school because of the seizures. When he attended Pembroke Elementary, he had to have a nurse accompany him; during the last few weeks of school, he received home-bound instruction.

The seizures prevent him from playing sports. Making friends is difficult, too.

The more severe seizures last 12 to 14 minutes and put him at risk of injuring himself when he falls on the floor. He sometimes has seizures at restaurants and at the mall. And as he gets older, it’s harder to administer the rescue meds.

The seizures are more common at night. Years ago, he’d gasp at the onset of one, so his mother could hear him from her bedroom. Lately, the gasps have stopped, so she sometimes moves him to her bed so she can detect the sudden stiffening of his body.

“I never dream, I never get into deep enough sleep,” she said. “I feel like I’m always listening for the least little noise.”

She’s willing to take a risk on a treatment that hasn’t had the full spectrum of study.

“I love my kid,” she said. “I want him to have a chance of normalcy. He hasn’t had that.”

Retrieved from:http://hamptonroads.com/2014/06/boy-epilepsy-marijuana-oil-could-be-key

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Does This Child Need Marijuana?

Lucy Rhoden, a three-year-old girl from Virginia, suffers from a rare type of epilepsy known as Dravet Syndrome. The genetic disorder causes severe seizures and, eventually, developmental issues. Her family, as well as several advocates for epilepsy patients, believe that marijuana could be the last-ditch medication she needs. Filmmaker John Picklap considers the case for treatment in this short documentary. “My daughter is actually higher right now, on the drugs that I gave her legally, with her doctor’s prescription, than she would be on medical cannabis,” says Lucy’s mother, Melissa Rhoden.

According to the Washington Post, several states have passed legislation that allows for the use of marijuana oils to treat epilepsy—and last week, Virginia Gov. Terry McAuliffe signed a similar bill. In January, the American Academy of Pediatrics recommended that marijuana be re-classified as a Schedule II drug, which would acknowledge its medicinal value and allow the FDA to be involved in more research studies.

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Wind Advisory Medical Marijuana Trial Shows Promise in Epileptic Children

WINCHESTER, Va. – When someone mentions marijuana, most might think of getting stoned – smoking or ingesting the plant for its tetrahydrocannabinol, or THC, the main psychoactive ingredient that gets you high.

According to an epileptic specialist in Winchester, this societal stigma is exactly why legalizing medical marijuana has been an uphill climb.

“The biggest misconception about medical marijuana is the confusion the public has about what it is,” said Dr. Paul Lyons, an adult and pediatric epileptologist with Winchester Neurological Consultants. “People think medical marijuana has psychocactive properties.”

Lyons had heard of using medical marijuana to treat epilepsy, but he wasn’t inspired to start researching until numerous parents started reaching out to him. He spent 13 months seeking approval from the Food and Drug Administration, along with numerous other federal and state agencies, before he was granted a license to administer oil-based medical marijuana.

There’s a clear difference, however, between Lyons’ marijuana and the kind that gets a person high.

“What I’m using is a purified, pharmaceutical grade extract of a plant,” Lyons said, “just as we do with other drugs.”

Epidiolex, the official name of Lyons’ liquid medical marijuana, is made of pure canabidiol (CBD), which is derived directly from the cannabis plant.

According to GW Pharmaceuticals, the United Kingdom-based company sponsoring the trial and manufacturing of the drug, Epidiolex is the first of it’s kind to contain no THC. GW Pharmaceuticals said it is the only company in the world that produces pharmaceutical grade pure plant-derived CBD, which can be administered orally as a suspension or via a feeding tube.

Lyons said while the pleas of many parents encouraged him to begin his research, it is their children, his patients, that kept him going.

“I believe that disease, particularly in children, is unfair,” Lyons said. “[Childhood is] a time when we should be burden-free, and able to explore our identity. All those normal developmental milestones of how to make friends, how to resolve fights, how to have sleepovers and how to play on a sports team – they’re deprived of those opportunities.”

Courtney Iser, a nine-year-old girl from Gore, Va., who’s suffered from epilepsy since she was six months old, is one of Lyons’ patients.

“You have to always monitor her,” said her mother, Sherri. “She can’t even be in another room by herself to play.”

Sherri and her husband David have tried everything they could think of to help with Courtney’s seizures, which have lasted as long as an hour. Courtney tried 12 different medications, a specialized diet for two years and even underwent physical surgery.

“The surgery helped bring her seizures down to one, maybe two minutes,” Sherri said. “But she still suffers constantly.”

It wasn’t until Sherri and David exhausted their options that they even began to think about medical marijuana.

“I started doing research on it, and realized that it’s extracted out of the plant into an oil, and that she wouldn’t be smoking it,” Sherri said.

Under his newly acquired license, Lyons has been able to prescribe Epidiolex to Courtney for the last two months. The oil is administered to Courtney through a syringe, by placing drops underneath her tongue twice a day.

Since starting Epidiolex, Courtney has had 23 seizure-free days, seven of which were consecutive. She is more alert, and active.

“I am an advocate for medical marijuana,” Sherri said. “Courtney is my number one, but if I can help other children out there, I would like to see all children seizure-free.”

Courtney’s results so far are good news to Lyons.

“Medical marijuana isn’t a cure, but it would give us another option in treating all types of patients with all kinds of epilepsy,” he said.

If statistics like this continue in trial patients, Lyons believes he has witnessed just the beginning of the legalization of medical marijuana in Virginia.

“I feel like there is strong evidence to suggest that medical marijuana will be legal in the state of Virginia, in my lifetime as a practicing physician.”

The medical marijuana trial is open to children who have a parent or guardian who can make it to Winchester Neurological Consultants for regular appointments. To find out more about the medical marijuana trial, and whether or not you qualify, you can call their office at 866-948-7055.

Copyright 2015 Nexstar Broadcasting, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Credit:http://www.your4state.com/story/d/story/medical-marijuana-trial-shows-promise-in-epileptic/21929/TC-QsCXJkkSsG_sodNLgVg

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Two VA Children Get Medical Marijuana Oil Through New Study

Winchester, VA – It’s been almost one year since our crews first met Caleb Thomas and his mother on their journey to get a form of medical marijuana approved in Virginia.

At that time, Caleb was having multiple seizures every day caused by epilepsy, but thanks to a doctor in Winchester, Caleb and another child just like him will be the first in Virginia to test out a Cannibidiol – or CBD – based treatment.

Last week, our crews traveled to Winchester to meet Courtney and Caleb…two children that have been plagued with epilepsy most of their lives.

Just before the start of a press conference, 9-year-old Courtney began having a seizure.

“Sometimes there’s triggers and sometimes you get signs, but sometimes they’re just out of the blue,  ” said Courtney’s mother, Sherri Iser.

Since Courtney was 6-months-old, her mother says this has become their normal way life.

The same can be said for Caleb Thomas – who we met back in May when his mother was desperately seeking anything that would help him.

“Caleb has been through every medication on the list except for three, and one of those could cause blindness. I would like to see another option,”

Almost a year later, there’s hope for both children – and maybe thousands more like them – thanks to Dr. Paul Lyons and a drug called Epidiolex.

“My goal for them is that we can enhance their development as well as control their seizures so they may have greater capacity for independence as young adults, ” Dr. Lyons said.

After just two months of taking the medication, both parents say the number of seizures has decreased.

“She’s had 23 seizure free days out of the 63 of the study, and 7 of those days were consecutive, ” Iser said.

“I come home from work and he’s playing with his toys and he’s smiling, ‘hi mommy’…to see him up and alive, it’s just very overwhelming in a happy good way, ” said Tracie Thomas.

For Dr. Lyons, getting permission for the study was no easy task. Even though the CBD-based solution won’t get patients high, it still took months to get approval from the FDA and DEA since marijuana is still a Schedule 1 drug.

Last Thursday, parents from all over the state spoke to lawmakers in the General Assembly about the importance of changing the laws to allow more access to patients.

Their children, just like Caleb and Courtney, are running out of options, but these select patients and researchers hope to change that.

“With perseverance and hard work, you can have meaningful quality of life as a person with epilepsy,” Dr. Lyons said.

Dr. Lyons says they will expand their research in the next few months. Right now they are looking for patients to participate in a randomized study.

If you know an adult or child with epilepsy that would like to get involved, go to clinicaltrials.gov, or call Jennifer Stanford, RN, MSN at 1-540-536-8978.

Credit:http://www.wset.com/story/27945294/two-va-children-get-medical-marijuana-oil-through-new-study

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Media Coverage of Dr. Lyons Medical Marijuana Trial

Dr. Paul Lyons has received approval from the FDA to proceed with a medical marijuana trial, the Northern Virginia Daily reports in a recent article entitled Area doctor gets FDA approval for medical marijuana trial (Demeria, 2014). Dr. Lyons will conduct the trial with two subjects, patients suffering from refractory epilepsy, which causes seizures that persist despite treatment with current approved medications.

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