Epidiolex Safely Lowers Seizure Frequency in Children, 3-Year Study Data Show

Epidiolex Safely Lowers Seizure Frequency in Children, 3-Year Study Data Show
0
(0)

When used alongside other anti-epileptic medications, Epidiolex (cannabidiol, CBD) safely reduces the frequency of seizures in children with Lennox-Gastaut syndrome (LGS), according to three-year data from a long-term extension study.

Findings were reported in an abstract, “Long-Term Safety and Efficacy of Cannabidiol (CBD) Treatment in Patients with Lennox Gastaut Syndrome (LGS): 3-Year Results of an Open-Label Extension (OLE) Trial (GWPCARE5),” accepted for presentation at the Annual Meeting of the American Academy of Neurology (AAN 2020).

Epidiolex, marketed by Greenwich Biosciences (a subsidiary company of GW Pharmaceuticals), contains CBD, a purified liquid formulation of plant-derived cannabis that has strong anti-seizure, anti-psychotic, and anxiolytic properties.

The medication is approved in the U.S. to treat seizures in children, ages 2 and older, with LGS and Dravet syndrome, two drug-resistant forms of epilepsy. It has also been approved in the E.U., under the brand name Epidyolex, as an add-on therapy to clobazam for the same indication.

Previous trials have found that Epidiolex was a safe and effective option to lessen the frequency of seizures in children with LGS.

Now, investigators reported findings from a third analysis of GWPCARE 5 (NCT02224573), an open-label, long-term extension study of children with LGS and Dravet who had previously participated in other GWPCARE core safety and efficacy trials.

The new analysis, which aimed to assess Epidiolex’s long-term safety and efficacy when used as an add-on therapy in children and adolescents with LGS, was based on data from 366 of 368 patients who had completed either GWPCARE 3 (NCT02224560) or GWPCARE 4 (NCT02224690).

During the extension study, participants were treated with an oral solution of Epidiolex (100 mg/mL).

Of the 366 eligible children (mean age of 16; 54% males) enrolled into the open-label extension trial, 119 (33%) withdrew. Patients were followed for a median period of 150 weeks (about three years).

At baseline, within a starting period of 28 days, these children experienced a median of 168 seizures, including 80 drop seizures. Drop seizures, also known as atonic seizures, are those with a sudden lose of muscle tone and patients become limp.

Epidiolex led to a median reduction of 48%–71% in the frequency of drop seizures, and a 48%–68% lesser frequency in total seizures.

During follow-up, nearly all children (96%) experienced side effect, and almost half (42%) had serious adverse events. The most common side effects observed included diarrhea, convulsions, fever, somnolence, vomiting, upper respiratory tract infections, and decreased appetite.

In 12% of children, adverse events led to treatment discontinuation. A total of 11 deaths were reported during the study, but none were determined to be related to Epidiolex by trial investigators.

“Long-term treatment with add-on CBD in patients with LGS produced sustained seizure reductions, with no new safety concerns,” the researchers wrote.

Joana holds a BSc in Biology, a MSc in Evolutionary and Developmental Biology and a PhD in Biomedical Sciences from Universidade de Lisboa, Portugal. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells — cells that made up the lining of blood vessels — found in the umbilical cord of newborns.
Total Posts: 0
Ana de Barros, PhD Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.
×
Joana holds a BSc in Biology, a MSc in Evolutionary and Developmental Biology and a PhD in Biomedical Sciences from Universidade de Lisboa, Portugal. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells — cells that made up the lining of blood vessels — found in the umbilical cord of newborns.
Latest Posts
  • Epidiolex
  • Soticlestat
  • cannabidiol Epidiolex
  • Please do not use this image. It's been used too often!

How useful was this post?

Click on a star to rate it!

Average rating 0 / 5. Vote count: 0

No votes so far! Be the first to rate this post.

As you found this post useful...

Follow us on social media!

We are sorry that this post was not useful for you!

Let us improve this post!

Tell us how we can improve this post?

Leave a Comment

Your email address will not be published. Required fields are marked *