cbd oil for post stroke seizures

Parents Demand Medical Marijuana for Epileptic Kids

PITTSBURGH — In room 716 of the Children’s Hospital of Pittsburgh, 12-year-old Hannah Pallas is motionless, but for an occasional turn of her head and blink of her eyes, following a series of life-threatening seizures. On the same day, 5-year-old Sydney Michaels is down the hall in room 749, waiting to be discharged after 15 grand mal seizures within 36 hours.

Their mothers have known each other for years, though it’s a hapless coincidence caused by their daughters’ epilepsy that brings them to the pediatric unit on the same day.

The two women are part of a tenacious group of parents and national marijuana advocates demanding that politicians and state legislators legalize medical marijuana treatment for their children, whose medications have had limited success treating seizures and other severe conditions.

“This is something that needs to happen across the country so that every child who might need this would have access,” said Julie Michaels, Sydney’s mother and a member of Campaign for Compassion, which is pushing for comprehensive medical marijuana laws in Pennsylvania. “Why should the state lines be the factor as to whether my child can get help or not?”

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Sydney is one of only a few hundred children around the country enrolled in a clinical trial to test the use of marijuana-based treatments for epilepsy. But Hannah is not.

“I’m watching my daughter die every day,” said Heather Shuker, Hannah’s mother. “Hannah has so many seizures, and every seizure could take her from me. I firmly believe that medical cannabis will help her.”

“There’s so much that I want for her right now that she just can’t do,” Michaels said about Sydney. “Just being able to go out and experience life, to be able to go out and play in the yard without fear of seizures starting.”

Since 2014, 17 states have legalized the use of marijuana-derived cannabidiol (CBD) in children: Utah, Wyoming, Wisconsin, Iowa, Missouri, Oklahoma, Texas, Louisiana, Mississippi, Alabama, Tennessee, Georgia, Florida, South Carolina, North Carolina, Kentucky and Virginia. The laws are intended mostly to treat intractable epilepsy and, in some cases, other conditions. Florida, Georgia and Louisiana, for example, allow limited medical marijuana use for cancer treatment.

CBD is the non-psychoactive component of the marijuana plant. It has yet to be proven scientifically as a successful treatment, though anecdotal evidence suggests it helps some children. Tetrahydrocannabinol (THC) is the part of the plant that produces a high, but it is also known – if not proven – to treat pain, nausea and insomnia, among other symptoms.

The 17 states that recently passed CBD legislation all placed limits on the THC concentration of medical marijuana extracts to minimize the psychoactive effects of the medication. They range from 0.3 percent in Oklahoma to 5 percent in Georgia.

Shuker said her daughter Hannah, diagnosed with severe intractable epilepsy and Lennox-Gastaut syndrome, has about 250 seizures a month. They have tried more than 18 different seizure medications and special diets.

Pharmaceuticals made her daughter’s seizures worse, Shuker said. Hannah now has a surgical feeding tube because she can no longer swallow on her own. Doctors have told Shuker that Hannah’s only remaining option to try to reduce the seizures is a brain surgery procedure, with risks of infection, increased seizures or stroke.

Meanwhile, visits to the emergency room and pediatric ward have become routine, Shuker and Michaels say their lives revolve around doctor appointments and unexpected stays in the hospital. While other mothers track their children’s height on walls with markers, these mothers track dates and times and numbers of seizures on homemade charts.

Sydney is one of 25 children in the clinical trial at Children’s Hospital of Philadelphia who are receiving doses of Epidiolex, a purified CBD created by London-based GW Pharmaceuticals. Part of the drug’s attraction is that it is low in THC.

“Prior to this study, she couldn’t do a puzzle. After about two weeks, she was whipping through puzzles on an iPad and we’re like, ‘Who is this kid?’” Michaels said. “We’re talking about a kid who was seizing easily from 1,000 to 3,000 times in a week. It was incredible.”

Dr. Eric Marsh, assistant professor of neurology and pediatrics at the Children’s Hospital of Philadelphia and attending physician for the Philadelphia clinical trial, was cautiously optimistic about the overall results, with parents reporting a 50 to 60 percent reduction in their children’s seizures. However, Marsh encourages families to wait until marijuana-derived medications earn Food and Drug Administration (FDA) approval.

“There’s so much interest and excitement over this that it really could skew results,” Marsh said. “It does seem that CBD interacts with some of the other medications. Clearly it’s not a miracle drug. It has interactions with other drugs, and it does have side effects.”

Despite the lack of scientific evidence, families have become medical refugees – leaving their homes to chase the uncertain prospect that medical cannabis may save their children’s lives. Many believe medical cannabis is their last option.

Many have moved from their home states to Colorado, where marijuana treatments are legal. According to the Colorado Department of Public Health and Environment, there are 434 children on the state’s medical marijuana registry. In August 2013, there were 60.

Earlier this year, 9-year-old Alexis Bortell of Dallas had one of her worst seizures and was taken to a hospital. For moments at a time, she stopped breathing. A week later, she suffered stroke-like symptoms, said her father, Dean Bortell.

Anti-seizure pharmaceutical drugs like Depakote and Carbatrol did little to stop her seizures and seemed to incite a range of side effects such as anger. “We had to put all the knives in the house up out of her reach,” her father said.

“She was just not herself,” Dean Bortell said, “ That’s when Liza and I, my wife, decided it’s time to go.”

The Bortells moved to Colorado earlier this year. Today, Alexis wakes up early every morning to take her dose of CBD oil with a drop of THC in her new home in Littleton, Colorado. She swallows the oil through a syringe twice a day.

“I would describe it like an earthy taste,” Alexis said.

What follows is a very active schedule: playing with Purdy the service cat, Skyping friends in Texas, shooting hoops, golfing practice, playing at the park, swimming and ending the day eating frozen yogurt at Yogurtini.

“It has changed my daughter’s life in the most positive way, humanly possible,” Bortell said, adding that she hasn’t had a seizure in 100 days. “We’ve got our little girl back.”

Kevin Chapman, a neurologist at Children’s Hospital Colorado, sees many of the children using cannabis oil to treat their seizures. He authored a report last year that measured the effectiveness of using cannabis extracts to reduce seizures. He and other doctors surveyed the parents of 75 children in Colorado and concluded that 33 percent of parents said they saw their children’s seizures reduced by more than 50 percent.

The Denver neurologist understands the limitations of his study, starting with the sample size of 75 children – who all used different oils, each with its own chemical make-up. Making matters more complicated, the participants had different types of epilepsy that ranged in severity. The study also depended on parental reporting, which Chapman says can produce biases.

The report said the study results highlighted “the need for controlled studies to evaluate the efficacy and safety of oral cannabis extracts for treatment of pediatric epilepsies.”

“Families picked up and moved to Colorado with the hopes that it’s going to make their child better,” Chapman said. “All of us in that situation would hope that it really works, and therefore we think that there might be some bias that could skew the numbers to suggest that it’s a bit more effective.”

Dr. Larry Wolk, chief medical officer and director of the Colorado health department, said he could not ignore the anecdotal success stories reported by parents, but more research needs to be done.

“You only hear about the children it helps. The problem is that it doesn’t help everyone. The results are mixed,” Wolk said. “As a physician, I’m worried that we’re rushing this.”

Promising Results for CBD in Tuberous Sclerosis Complex-Related Seizures

Formulation of purified cannabidiol (CBD) may offer patients with tuberous sclerosis complex (TSC) a new treatment option for seizures, according to study results presented at the American Epilepsy Society 2019 Annual Meeting.

A purified oral solution form of CBD that contains only trace amounts of tetrahydrocannabinol, was recently approved by the Food and Drug Administration for the treatment of Dravet syndrome and Lennox-Gastaut syndrome, which are also associated with resistant epilepsy. As many patients with TSC struggle with therapy-resistant epilepsy, the goal of the current study was to assess the efficacy and safety of adjunctive CBD in this population.

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The randomized, double-blind, controlled trial included patients with TSC treated at 46 sites in 6 countries. All patients were diagnosed with TSC-associated focal and generalized seizures and had previously tried and discontinued a median of 4 anti-epileptic drugs. The participants were randomized to receive CBD at 25 mg/kg/day (CBD25), 50 mg/kg/day (CBD50), or placebo for 16 weeks.

The primary outcome was percent change from baseline in TSC-associated seizure frequency for CBD, compared to placebo.

The study included 224 participants (median age 11 years): 75 treated with CBD25, 73 treated with CBD50 and 76 treated with placebo. The subjects were actively treated with a median of 3 anti-epileptic drugs, most commonly valproate (45%), vigabatrin (33%), levetiracetam (29%), and clobazam (27%).

Treatment with CBD was associated with a significantly greater decrease in TSC-related seizures, compared to placebo: 49% for CBD25 (P =.0009), 48% for CBD50 (P =.0018), compared to 27% decrease for placebo. A higher rate of participants treated with CBD had a 50% reduction in seizure frequency, compared to placebo: 36% for CBD25 and 40% for CBD50, compared to 22% for placebo.

Treatment with CBD was also associated with a significantly greater reduction in total seizure frequency, compared to placebo: 48% for CBD25 (P =.0013) and 48% for CBD50 (P =.0018), compared to 27% for placebo.

Caregivers reported an overall improvement in 69% of those treated with CBD25 (odds ratio [OR], 2.25; P =.0074), 62% of those taking CBD50mg (OR, 1.77; P =.0074) and 40% of those who had the placebo.

Adverse events were very common and documented in 93% of patients treated with CBD25, 100% of those treated with CBD50 and 95% of those in the placebo group. The common adverse events were diarrhea (31% of patients treated with CBD25; 56% of those treated with CBD50; 25% of those in the placebo group), decreased appetite (20%, 23%, 12%, respectively) and somnolence (13%, 26%, 9%, respectively).

Treatment discontinuation due to an adverse event was more common with CBD25 (8 patients) or CBD50 (10 patients), compared to placebo (2 patients).

Elizabeth Thiele, MD, PhD, senior author of the study, director of pediatric epilepsy and director of the Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital, and professor of neurology at Harvard Medical School, Boston concluded that these findings suggest “lower dose of 25 mg/kg (of weight) provides the same benefit with fewer side effects compared to a dose of 50 mg/kg and will likely be the recommended dose.” Dr Thiele also notes that “our findings suggest this formulation of purified CBD offers patients with TSC a new treatment option for their very difficult-to-manage seizures.”