Pubdate: Thu, 01 Dec 2016
Source: Victoria Times-Colonist (CN BC)
Copyright: 2016 Times Colonist
Contact:  http://www.timescolonist.com/
Details: http://www.mapinc.org/media/481
Author: Sheryl Ubelacker
Page: D1

SICK KIDS GET POT-BASED DRUG

Nanaimo firm will supply cannabis for pioneering research to help
children with epilepsy

Researchers at Toronto's Hospital for Sick Children are about to begin
a clinical trial using cannabis extracts to treat children with severe
epilepsy whose seizures cannot be controlled with existing
medications.

The trial is believed to be the first in Canada to test an oral
preparation that contains both CBD and THC, compounds in marijuana
that have been shown in the laboratory and through anecdotal reports
to have anticonvulsant properties in children with treatment-resistant
epilepsy.

CBD, or cannabidiol, is one of hundreds of active chemicals in the
marijuana plant, many of them touted to have medicinal properties.
THC, or tetrahydrocannabinol, is the psychoactive ingredient that
produces the "high" associated with pot.

While research has found CBD to be effective in reducing seizures,
there has been no rigorous study that has looked at the combination of
CBD and THC, said pediatric neurologist Dr. Blathnaid McCoy, who will
lead the clinical trial beginning early next year.

But finding a new therapy is critical. Despite doctors having an
arsenal of more than 40 anticonvulsant medications, 30 per cent of
their patients with severe epilepsy are unable to bring their seizures
under control with any of the drugs.

"There are severe developmental, cognitive, behavioural and motor
delays that happen when children have uncontrolled epilepsy," said
Catherine Jacobson, director of clinical research at Tilray, a
Nanaimo-based medicinal marijuana producer that will be providing the
oral CBD-THC preparation for the clinical trial.

"It's an absolutely devastating disease to live with," said Jacobson,
whose seven-year-old son has intractable epilepsy. "So the need to
develop new medications that will control seizures in these children
is very high."

The Sick Kids study will enrol 20 children ages one to 18 who have
Dravet syndrome, a rare and debilitating form of epilepsy that begins
in infancy. The condition, which is caused by a genetic mutation,
accounts for about one per cent of all cases of epilepsy.

"It varies massively, but [children with] Dravet syndrome often have
multiple seizures every day and they can have quite prolonged
seizures," McCoy said.

"And in line with that, they also have a significant disruption in
normal development, so they can have challenges with their mobility,
with feeding difficulty, with interactions.

"Certainly, when the epilepsy is difficult to control and very
treatment-resistant from early on, they can have catastrophic outcomes
in terms of their development."

Dawn Bellefeuille's youngest son, Sean, is one of those
children.

He suffered his first seizure at two months old, and they grew worse
and more frequent over time, said Bellefeuille, who has three older
children who are not affected by the condition.

Sean's seizures, sometimes 40 a day, have severely delayed his
development.

At 13, he is virtually non-verbal and cannot dress, feed or go to the
toilet himself. He attends a special-needs school, but requires
around-the-clock care.

"He's been on umpteen different drugs since he was born," Bellefeuille
said from Ottawa. "He didn't take his first steps until be was four
years old. He didn't sit up on his own until he was 18 months old."

While Sean is still taking a couple of standard anticonvulsant
medications, it wasn't until his parents started giving him a
high-CBD, low-THC cannabis oil that the number of their son's daily
seizures dropped dramatically, allowing him to cognitively advance.

"He said 'Mom' for the first time a year ago," said Bellefeuille,
describing her son as a mischievous imp with a grin that makes "all
your troubles just go away."

"The first time he had a temper tantrum, we cheered because he never
showed a preference for anything," she said.

"It's only been the last two years that cognitively he seems to be
coming alive, and it's only been since the CBD oil was
introduced."

Bellefeuille buys the cannabis oil on prescription from Cannimed, a
licensed medicinal marijuana producer in Saskatoon, for about $600 a
month.

But she said it is trial and error for parents to decide what dose is
safe and most effective for their child because research to guide both
doctors and families has not been conducted on CBD-THC
combinations.

"This is the hard part with Dravet," Bellefeuille said.

"No two children are the same. No two children respond to the same
medications the same way."

The Sick Kids trial will look at how well the CBD-THC combination is
tolerated by test subjects, what side-effects may emerge, and what
dose seems optimal.

If the safety and dose-related results are favourable, researchers
would then follow with a larger randomized control trial, in which
half the participants would get the cannabis drug and the remainder
would receive a placebo, to see if the CBD-THC treatment is superior
in reducing or eliminating seizures.

Bellefeuille said she would enrol Sean in such research "in a
heartbeat" if it could help determine what cannabis preparation would
be ideal for her son, whose seizures since starting cannabis oil are
down to about one "bad one" a day.

"I'm not asking for zero. While that would be ideal, I just want him
to be able to learn and to advance further than he's capable of doing
now," she said.

"I want him to be able to fly to the best of his ability."
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MAP posted-by: Matt