Clinical Trials Using Cannabis-Based Drug Showing Promise For Epilepsy

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Hank Kovach’s experience mirrors the recent success stories of other children with drug-resistant epilepsy.

Wracked by frequent, daily seizures that delayed his brain development, the 7-year-old Chicago boy was unable to speak, learn much or even sleep without waking up in tears after an hour or two. Conventional drugs didn’t help much.

But after he began using a marijuana extract last year, his parents said, they were astounded when Hank went six months without a seizure. He began uttering sounds, learning numbers and colors, and, for the first time, sleeping through the night.

“This has been life-changing for our family,” said his mother, Megan Turner. “We can actually see Hank be a happy little boy again.”

Hank’s story differs, though, from similar tales of patients treated through state medical pot programs; Hank was part of a clinical trial authorized by the federal government and conducted by a respected medical institution, Lurie Children’s Hospital of Chicago.

Lurie is taking part in what is believed to be the first clinical trial in the U.S. of cannabidiol, an oil extracted from pot that contains none of the THC that gets users high. Though further study is needed, preliminary results showed it cut seizures in half for patients.

With Illinois on the verge of making medical marijuana available to those who suffer from any of about 40 medical conditions, including epilepsy, doctors, patients and legislators are closely watching the results of Lurie’s trial.

For years, advocates and critics of medical pot have agreed that much more study needs to be done on its effects. Federal law, which classifies marijuana as being as dangerous as heroin, has made it difficult to conduct research. Now, the U.S. Food and Drug Administration is considering fast-track approval for the cannabidiol Epidiolex, and Lurie is part of a nationwide trial of its effectiveness.

Even as about half the states now allow medical pot, controversy over its efficacy remains. A recent review analyzed dozens of scientific studies on the effectiveness of medical marijuana. The report found that while some studies showed pot to be effective for treating maladies like chronic pain and muscle spasticity, the results of other studies pointing to pot’s effectiveness were overstated.

To address such concerns, the current phase of the Lurie trial is using the gold standard of medical research: a randomized, double-blind, placebo-controlled study. That means that neither doctors nor patients know who is getting the drug and who is getting an impostor oil with no medical effect.

Hank was among 25 patients who began receiving Epidiolex, distributed by dropper, at Lurie last summer in the first phase of the trial to test the drug’s safety. Though reports of side effects were minimal, 6 percent of participants nationwide dropped out because of side effects including drowsiness.

The current phase of the study, conducted at hospitals across the country, involves up to about 500 children and adults with rare and catastrophic forms of epilepsy. London-based GW Pharmaceuticals, which makes the drug, plans to get the final results by early next year and apply to the FDA for the drug’s use by prescription in mid-2016.

Dr. Linda Laux, who leads the study at Lurie, reported that patients had better concentration, sleep and behavior, and some became more verbal and showed better coordination.

“The (preliminary) study was very promising,” she said, “It was enough to go forward with medical trials for FDA approval.”

GW Pharmaceuticals already sells Sativex — a 50-50 mix of cannabidiol and THC, used to treat spasticity in people with multiple sclerosis — in 27 countries, but that’s also not yet approved in the U.S.

Epidiolex is much more reliable than the cannabis found in many state medical pot programs because it is going through the FDA-approval process and because each dose is standardized so patients know what they’re getting, GW spokesman Stephen Schultz said.

A study in June in the Journal of the American Medical Association found discrepancies between what edible marijuana product labels stated and the actual content. Lab tests of marijuana products from dispensaries in California and Washington found that only 17 percent were accurately labeled for THC and cannabidiol.

“There are so many question marks around the use of dispensary products that the ultimate solution we believe is an FDA-approved pharmaceutical medicine,” Schultz said. “So you know what you take today is the same medicine you’ll take a year from now, with full dosing instructions you can count on.”

In Illinois, cultivation centers for medical marijuana are required to have laboratories document sample testing and to limit pesticides and contaminants. The state may also conduct random testing.

Parents of patients in the Lurie study who spoke to the Tribune support the state program, though they won’t have to participate because they may keep receiving the raspberry-flavored Epidiolex syrup through the hospital.

One of those patients is Katie Dysart, a 12-year-old girl from out of state who suffered severely debilitating seizures known as Doose syndrome.

Shortly after Katie starting taking a teaspoon of Epidiolex twice daily, there was a dramatic reduction in her seizures, from several a week to one every couple of months, said her mother, Elizabeth Dysart. Katie made big strides in reading and vocabulary, and personal interactions.

“We can’t believe it. The doctors can’t believe it,” Dysart said. “Everybody’s just amazed at this child that has emerged. … Now we have hope she eventually will be the person she was created to be.”

News Moderator: Jacob Redmond 420 MAGAZINE ®
Full Article: Clinical trials at Lurie of pot drug to help epilepsy show promise – Chicago Tribune
Author: Robert McCoppin
Contact: rmccoppin@tribpub.com
Photo Credit: Jennifer Simonson | MPR News
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