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Efficacy and Safety of Cannabidiol in Children and Young Adults with Epilepsy

Efficacy and Safety of Cannabidiol in Children and Young Adults with Epilepsy

Medical Marijuana, CBD and Epilepsy Research

Photo credit Epilepsy and Medical Cannabis

Medical Marijuana Research Breakthroughs 2015.

American Epilepsy Society, Abst. 3.397, 2015.

Layman's Abstract.

In the largest study of its kind, the American Epilepsy Society found that a component of Medical Marijuana, Cannabidiol effectively reduced or eliminated epileptic seizures in children and adults. 

Background

Cannabidiol (CBD) is typically the most abundant non-psychoactive cannabinoid found in Medical Marijuana. Previously, Medical Marijuana was demonstrated to counteract convulsions and seizures in many animal models. Anecdotal evidence suggests efficacy of CBD in children with treatment-resistant epilepsies such as Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS).

Methods

261 young people with treatment-resistant epilepsies were enrolled in an observational study to access the compassionate use of CBD, a non-psychoactive component of Medical Marijuana.

Baseline Study

Over a 4 week period, epilepsy patient caregivers kept an account of all seizures.  No medication was administered during this period.

Study

Patients were dosed orally with a high-pure alcohol extract of non-psychoactive CBD (Epidiolex).  Dosage was gradually increased from 2-5 mg/kg/day to 25 mg/kg/day, where intolerance occurred. Patients were observed and tested at regular intervals throughout the initial 12 weeks of the trial.   The level of CBD, as an antiepileptic drug (AED), was used to monitor compliance, effects of dosage and established maximum tolerated dosage as measured in blood tests.  Hematologic, liver, kidney function was also tested to monitor side-effects.

Results

Study Parameters

  • length of study: 12 weeks +
  • number of patients studied: 261
  • sex: 52% male, 48 % female
  • average age: 11.8 years
  • age range: 4 months to 41 years
  • average weight: 38 kg; range 6.4-127 kg
  • epilepsy diagnosed types: DS 17%, LGS 15%

Efficacy - Seizure Reduction

  • median overall seizure frequency reduction was 45.1% in all patients
  • * median seizure frequency reduction  was 62.7% in DS patients *
  • * median atonic seizure frequency reduction in LGS patients was 71.1% *
  • reduction in seizures among all patients, 47% with a greater than 50% reduction
  • seizure-freedom at 3 months occurred in 9% of patients
  • seizure-freedom at 3 months occurred in 13% of DS patients
  • co-therapy of CBD with Clobazam was associated with a higher response, with a greater > 50% convulsive seizure reduction at 57%

Tolerance - Side Effects

  • safety data from 313 patients equalling 180 patient years was recorded
  • adverse events occurred in ≥10% of patients included somnolence (23%), diarrhea (23%), fatigue (17%), decreased appetite (17%), convulsions (17%) and vomiting (10%)
  • 4% had an adverse event leading to discontinuation of CBD.
  • 12% withdrew, primarily due to lack of efficacy
  • 5% had serious adverse effects that were considered treatment-related, including, altered liver enzymes, status epilepticus/convulsion, diarrhea, weight loss.

Conclusion

Results from this uncontrolled study are consistent with the consensus of literature findings; CBD is a promising treatment for most epileptic conditions and is worthy of serious clinical investigation.  Additionally, previous claims that CBD is well tolerated, was substantiated in this study; the average young individual can comfortably handle doses up to 25 mg/kg/day.  The CBD drug Epidiolex, is now being investigated in randomized controlled studies of Epilepsies, DS and LGS.

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Labels: Epilepsy Spasm cbd seizure cbd cannabidiol children kids clinic md doctor trial letal strains with cbd psychoactive thc

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