One of the most painfully frustrating events in our practice of Neurology since the times of residency training has been the encounter with a refractory Epilepsy syndrome in a young patient. Not only we witness the suffering of the disgraced patients, who are losing intellectual capacity and the promise of a fruitful future, but also the terrible frustration of their parents and loved ones. Lenox-Gastaut syndrome is exactly that: an epilepsy variant that attacks young patients with “drop seizures” that are resilient to effective, long-term and non-toxic pharmacologic treatment.

A multi-center study that enrolled 171 patients form 24 clinical centers form the United States, the Netherlands and Poland studied the effects of the administration of Epidiolex, a CBD purified drug that does not contain any of the psychoactive components of Cannabis. Patients from the age of 2 and 55 years old who had failed to show improvement with at least two anti-epileptic drugs were eligible to participate; their mean age was 15 years old with six drug failures. They all had to have slow (less than 3 hertz) spike and wave patterns in their electroencephalogram, more than one type of seizure for at least six months and at least two drop seizures per week.

The participants were randomized to receive 20 mg/kg purified CBD oil daily (divided twice daily) or a matched placebo for 14 weeks. Their families actively participated as they helped them record the number of drop seizures and related events during the study. They were evaluated four times in their respective medical clinics and twice with a special telephone interview. The investigators studied the percentage change of drop seizures during the treatment period of 86 patients that received the drug and the 85 patients who were part of the placebo group. We must point out that all patients continued to receive their properly prescribed anti-epileptic treatment.

The median percent reduction in monthly drop seizures from baseline to the end of the study was 43.9% in the group receiving Epidiolex compared to 21.8% in the placebo group. Some patients receiving the drug even had a 50% reduction in seizures and three patients were even seizure-free during the whole study; nobody in the placebo group had a seizure-free period. There were some adverse events in both groups, including diarrhea, fatigue, fever and vomiting. Amongst the noted drug interactions, the patients taking Clobazam had an increase in its active metabolite, which led to higher sedation. Thirty-six treated patients that were also taking Valproic Acid had an increase in liver enzymes, which resolved after the CBD was stopped.

After the study was stopped in October 2015, an open-label extension study was started.

What do you think? Please tell us.

Don’t leave me alone.

11 thoughts on “Cannabis in Lennox-Gastaut Syndrome

  1. Mmmm… good evening once more!

    I’m fascinated but not necessarily surprised that the drug seemed to have a positive impact. What I was wondering throughout was if there was any data concerning the incidence of antiphospholipid antibody syndrome in the sample groupings; I read this week some statistics that suggest up to 1 in 5 patients exhibiting forms of epilepsy have APS and I’m curious if the CBD impacted those patients more or less and if it altered the effectiveness of their anticoagulation. Any thoughts?

    Liked by 1 person

  2. Morning, dottore.
    Interesting read. The placebo effect has always intrigued me and then I was a part of a study once (long story, will share it one day), but didn’t react well to the new drug. I found out later I was in the placebo group.
    I don’t know if it was bad luck or complicated disease, but all the other patients in the same group reacted very well. Oh, well, c’est la vie, take it or leave it.

    What do you think, my dear?
    Have a nice day. Hugs.

    Liked by 1 person

    1. Good morning and thanks for your nice commentary cara amica. Let me clarify a point from the beginning: this is one of the first double blind studies on Cannabis where the study of a control group (that did tot take the Epidiolex) assures the elimination of the placebo effect. This is a promising study on this drug for a terrible disease that affects young people. Yes, the placebo effect is very important in medicine but researchers must make sure that it is not the critical factor in the effectiveness of a potentially beneficial drug.
      It is always a pleasure to wake up and read your sweet words, whatever they are. Un baccione.
      Arrivederci!

      Liked by 1 person

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