Cannabinoids in treatment-resistant epilepsy: A review

O’Connell, Brooke K.; Gloss, David; Devinsky, Orrin

doi:10.1016/j.yebeh.2016.11.012

Cited by 173 publications

(111 citation statements)

References 44 publications

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“…Participants were given a standardized breakfast, and 15 minutes later, they were given either oral CBD (600 mg) or placebo in a double-blind fashion. This is a dose known to cause anxiolytic effects in humans and is comparable with what is used clinically (19,(37)(38)(39). Study medication consisted of capsules containing either 100 mg of CBD or excipients, which were a gift from GW Pharmaceuticals.…”

Section: Methodsmentioning

confidence: 99%

A single dose of cannabidiol reduces blood pressure in healthy volunteers in a randomized crossover study

Jadoon¹,

Tan²,

O’Sullivan³

2017

JCI Insight

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Section: Methodsmentioning

confidence: 99%

A single dose of cannabidiol reduces blood pressure in healthy volunteers in a randomized crossover study

Jadoon¹,

Tan²,

O’Sullivan³

2017

JCI Insight

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“…An open-label trial 9 suggested that CBD can reduce seizure frequency in children and young adults with treatment-resistant epilepsy, and three randomized, placebo controlled phase III trials have been completed in Dravet and Lennox Gastaut syndromes (NCT02091375, NCT02224560, NCT02224560) and preliminary reports support efficacy in both syndromes 10 . Parents of children with severe epilepsies treated with vernacular CBD preparations reported improved mood, behavior, language, alertness, motor skills, and sleep, but also drowsiness, fatigue and reduced appetite 6; 11 .…”

Section: Introductionmentioning

confidence: 99%

Quality of Life in Childhood Epilepsy in pediatric patients enrolled in a prospective, open‐label clinical study with cannabidiol

et al. 2017

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Summary Recent clinical trials indicate that cannabidiol (CBD) may reduce seizure frequency in pediatric patients with certain forms of treatment-resistant epilepsy. Many of these patients experience significant impairments in quality of life (QOL) in physical, mental, and social dimensions of health. In this study, we measured the caregiver-reported Quality of Life of Childhood Epilepsy (QOLCE) in a subset of patients enrolled in a prospective, open-label clinical study of CBD. Results from caregivers of 48 patients indicated an 8.2 ± 9.9 point improvement in overall patient QOLCE (p<0.001) following 12 weeks of CBD. Subscores with improvement included energy/fatigue, memory, control/helplessness, other cognitive functions, social interactions, behavior and global QOL. These differences were not correlated to changes in seizure frequency or adverse events. The results suggest that CBD may have beneficial effects on patient QOL, distinct from its seizure-reducing effects, however further studies in placebo-controlled, double-blind trials are necessary to confirm this finding.

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“…[7][8][9][10] In fact, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted CBD preparations the "orphan drug" designation for use in the treatment of epilepsy in children (Dravet and Lennox-Gastaut syndromes) and neonatal asphyxia. 9,10,15,16 One of the main drawbacks in many efficacy clinical trials with cannabinoids is that the available products are not manufactured under conditions of Good Manufacturing Practice that safeguard their quality and reproducibility, because they are not considered regulated medications. 13 It appears to be safe in humans and animals.…”

mentioning

confidence: 99%

Single‐Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology

Atsmon

Heffetz²,

Deutsch³

et al. 2017

Clinical Pharm in Drug Dev

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Cannabidiol (CBD) is the main nonpsychoactive component of the cannabis plant. It has been associated with antiseizure, antioxidant, neuroprotective, anxiolytic, anti-inflammatory, antidepressant, and antipsychotic effects. PTL101 is an oral gelatin matrix pellets technology-based formulation containing highly purified CBD embedded in seamless gelatin matrix beadlets. Study objectives were to evaluate the safety and tolerability of PTL101 containing 10 and 100 mg CBD, following single administrations to healthy volunteers and to compare the pharmacokinetic profiles and relative bioavailability of CBD with Sativex oromucosal spray (the reference product) in a randomized, crossover study design. Administration of PTL101 containing 10 CBD, led to a 1.7-fold higher C and 1.3-fold higher AUC compared with the oromucosal spray. T following both modes of delivery was 3-3.5 hours postdosing. CBD exhibited about a 1-hour lag in absorption when delivered via PTL101. A 10-fold increase in the dose resulted in an ∼15-fold increase in C and AUC. Bioavailability of CBD in the 10-mg PTL101 dose was 134% relative to the reference spray. PTL101 is a pharmaceutical-grade, user-friendly oral formulation that demonstrated safe and efficient delivery of CBD and therefore could be an attractive candidate for therapeutic indications.

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Cannabinoids in treatment-resistant epilepsy: A review

Cited by 173 publications

References 44 publications

A single dose of cannabidiol reduces blood pressure in healthy volunteers in a randomized crossover study

A single dose of cannabidiol reduces blood pressure in healthy volunteers in a randomized crossover study

Quality of Life in Childhood Epilepsy in pediatric patients enrolled in a prospective, open‐label clinical study with cannabidiol

Single‐Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology

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