Topical CBD gel shows promising activity in hard-to-treat epilepsies


By Mardi Chapman

6 Sep 2021

Professor Ingrid Scheffer

Cannabidiol (CBD) transdermal gel is safe, well tolerated, and associated with reductions in seizure frequency and disease burden in children and adolescents with developmental and epileptic encephalopathies (DEEs).

An Australian and New Zealand study, published in JAMA Network Open, comprised 48 patients 3-18 years of age with a wide range of DEE syndromes and aetiologies and a high rate of comorbidities.

Patients were already using a mean of 2.7 antiseizure medicines including sodium valporate (71%), clobazam (52%), levetiracetam (35%) and lamotrigine (33%).

Over the 6.5 month treatment period of twice daily 4.2% topical CBD gel, most patients (96%) reported at least one treatment-emergent adverse event – commonly URTI, nasopharyngitis, somnolence and vomiting.

The study found 60% of patients experienced a mostly mild treatment-related adverse event such as application site dryness, pain and somnolence.

One patient with a history of keratosis pilaris had an application site reaction with intense erythema and discontinued the study medication. The reaction was determined to be an irritant dermatitis complicated by a secondary bacterial skin infection and not due to hypersensitivity to the gel.

A low rate of gastrointestinal adverse events was considered a potential significant benefit of transdermal delivery of CBD.

The study found the median seizure reduction was 12.3% from baseline through the treatment period.

“The seizure types that showed the greatest median response to CBD transdermal gel were focal impaired awareness seizures (reduction, 44.5% [−17.8% to 59.1%]) and tonic-clonic seizures (reduction, 22.7% [−6.8% to 62.3%]).”

Validated tools – the modified Epilepsy and Learning Disabilities Quality of Life (ELDQOL-modified) scale and the Sleep Disturbance Scale for Children25 (SDSC) – showed significant improvements in child behaviour, mood and sleep.

Qualitative assessments from parents or caregivers were also mostly about improvements (84%).

“The most frequently cited improvements were in alertness (17 of 43 patients [40%]), reduction in seizure frequency (16 of 43 [37%]), engagement or participation (15 of 43 [35%]), cognition (14 of 43 [33%]), attending school on time and/or more often (12 of 43, 28%), and more energy and less fatigue (12 of 43 [28%]).”

The most common negative statements were related to difficulty in applying the study medication (11 of 43 [26%]) and reactions at the application site (8 of 43 [19%]).

The study, led by Professor Ingrid Scheffer from the University of Melbourne, said it was the first trial of a non-oral formulation of CBD in a cohort of children and adolescents with DEEs.

The findings highlighted “important benefits beyond seizure reduction that improve overall quality of life for patients and families.”

The investigators said a double-masked randomised clinical trial of CBD transdermal gel was now required.

Disclosures: The study was funded by Zynerba Pharmaceuticals. Professor Scheffer has served on its scientific advisory board and consulted for the company.


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