cbd epilepsy adults

Both adult and youth (18 years or younger) CBD users reported better quality sleep, compared with their peers in the control groups.

For their evaluation, the researchers analyzed data gathered between April 2016 and July 2020 from 418 participants — 230 women and 188 men — with 205 (49%) at least age 18 and 213 (51%) age 18 or younger. The participants included 71 adults with epilepsy who used artisanal CBD products for medicinal purposes and 209 who were caregivers of children or dependent adults to whom artisanal CBD products were given. The control group consisted of 29 adults with epilepsy who were considering the use of CBD products and 109 caregivers who were considering it for a dependent child or adult patient.

Epidiolex, a pharmaceutical formulation of CBD is approved by the FDA to treat three types of rare seizure disorders (Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex), but is not approved for the many other types of epilepsy. As a result, patients with other forms of epilepsy often seek alternative forms of CBD, including those evaluated in the new study.

Caregivers of patients currently using CBD products reported significantly less burden and stress, compared with caregivers in the control group (13% less).

Epilepsy, one of the most common nervous system disorders affecting people of all ages, is a neurological condition characterized by recurrent seizures. Treatment for epilepsy includes anti-seizure medications and diet therapy, such as forms of the ketogenic diet. Surgery may be an alternative treatment, especially when medications or diet fail to control seizures, or if drug side effects — including dizziness, nausea, headache, fatigue, vertigo and blurred vision — are too difficult for a patient to tolerate.

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Johns Hopkins Medicine researchers have shown that CBD may reduce the adverse effects associated with anti-seizure medications, and seems to improve other aspects of health and quality of life for patients with epilepsy. Credit: Public domain image

Artisanal (non-pharmaceutical) cannabidiol (CBD) products have become popular in recent years for their apparent therapeutic effects. CBD — a naturally occurring compound of the cannabis plant legally derived from hemp — is used widely as a naturopathic remedy for a number of health conditions, including epilepsy and seizure disorders. Now, Johns Hopkins Medicine researchers, in collaboration with the Realm of Caring Foundation and other institutions, have conducted an observational study with participant-reported data to better understand the impact these products may have on people with epilepsy.

Participants completed a web-based survey that included questions regarding quality of life, anxiety and depression, and sleep. They were prompted via email to complete follow-up surveys at three-month intervals for 14 months.

Cbd epilepsy adults

The phase 3 clinical trial <"type":"clinical-trial","attrs":<"text":"NCT02224690","term_id":"NCT02224690">> NCT02224690 (GWPCARE4) included 171 patients (aged between 2 and 55 years) with a diagnosis of LGS. Participants had to have taken one or more antiepileptic drugs (the most used was lamotrigine, valproate and CLB) at a stable dose for at least 4 weeks prior to screening as well as interventions for epilepsy. The first endpoint was to aim the efficacy of the CBD oral solution (GWP42003-P) as adjunctive treatment in reducing the number of drop seizures when compared to the placebo. The secondary endpoint was to assess the safety of CBD by measuring AEs using standard severity measures. Individuals were divided into two groups: 85 received placebo and 86 received a CBD at a dose of 20 mg/kg/day for 14 weeks. SAEs (pneumonia, viral infection, alanine aminotransferase increased, aspartate aminotransferase increased, γ-glutamyltransferase increased) occurred in the 23.26% of CBD group and in 4.71% of patients in the placebo group. Serious TEAEs (increased levels of alanine aminotransferase, aspartate aminotransferase and γ-glutamyltransferase) occurred in four patients in the CBD group. Instead, the most common no serious-AEs (vomiting, diarrhoea, loss of appetite and drowsiness) occurred in the 61.63% of CBD group and in 50.59% of patients in the placebo group. After 14 weeks of treatment, the monthly frequency of seizures decreased by a median of 43·9% from baseline in the CBD group. A reduction in seizures frequency of 50% or more, was reported in 44% of patients in the CBD group and in 24% of patients in the placebo group. The study found that in many patients treated with antiepileptic drugs that included CLB, a higher onset of somnolence was observed. High levels of transaminases were recorded in patients treated with valproate. Nevertheless, the high rate of AEs, the results showed that the administration of long-term CBD oral solution in patients with LGS determines the reduction in seizure frequency compared to placebo [76].

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A phase 2, multi-center clinical trial ( <"type":"clinical-trial","attrs":<"text":"NCT02551731","term_id":"NCT02551731">> NCT02551731) enrolled 9 children (6 months to 36 months) with a diagnosis of WS (Infantile Spasms) who have not responded to first-line therapies. CBD in oral solution was administered at the initial dose of 20 mg/kg/day or 40 mg/kg/day. The protocol provided the division of the study into two parts: Part A and Part B. In Part A was evaluated the efficacy, defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-electroencephalogram (EEG) and safety at day 14 of treatment. Instead, in Part B was evaluated the efficacy and the long-term safety up to 64 weeks of treatment. In Part A, 14.3% of children showed complete resolution of spasms and hypsarrhythmia (when present at baseline) on day 14. Only in 33% showed AEs, while no SAEs were recorded. No results of Part B of the clinical trial were recorded because only one subject has completed the study. Then, these results confirm the efficacy and safety of the CBD oral solution after 14 days of treatment.

Table 1

To date, available safety data show that the administration of CBD associated with other AEDs causes non-serious adverse events, which can be resolved reducing the dose of CBD and/or common AEDs. In this context, particular attention should be paid when CBD is associated with valproate and CLB. Specifically, abnormal liver function was noted in participants taking concomitant valproate, therefore, it is necessary to monitor serum levels of these compounds and their respective metabolites. Instead, when CBD is associated with CLB it induces an increase in its metabolites. Since the adverse effects are not serious, this association can be considered safe.

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CBD: Cannabidiol; TEAEs: Treatment-emergent adverse events; SAEs: serious adverse events.

4. Cannabidiol and Molecular Targets in Epilepsy

A phase 1/2 clinical trial <"type":"clinical-trial","attrs":<"text":"NCT03014440","term_id":"NCT03014440">> NCT03014440, aim to determine the safety and tolerability of CBD (Epidiolex) in addition to the anti-epileptic treatments in use, in patients aged 1 to 20 years with drug-resistant epilepsy. Antiepileptic therapy followed by patients had to be stable for at least 1 month. To date, there is no information available regarding the treatment, the doses used and the results.