CBD gel reduces seizures in children with DEE: BELIEVE trial

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2021-01-05 12:45 GMT | Update On 2021-08-20 10:46 GMT

Australia: Cannabidiol (CBD) transdermal gel (ZYN002, Zygel) helped to reduce seizure frequency in children and adolescents with developmental and epileptic encephalopathies (DEE), show results from phase II BELIEVE trial.

The findings of the study were presented at the American Epilepsy Society 2020 virtual annual meeting.

DEE are the most severe group of epilepsies. Children have drug-resistant seizures, developmental slowing often with regression, and psychiatric and motor disabilities. BELIEVE trial by Ingrid Scheffer, the University of Melbourne, Australia, and colleagues evaluated the safety, tolerability, and eﬃcacy of cannabidiol transdermal gel in children and adolescents with DEEs.

BELIEVE was an exploratory open‐label, multiple‐dose study of ZYN002 CBD transdermal gel in children and adolescents (aged 3 to < 18 years) with DEEs. During a 26‐week treatment period, weight-based doses of ZYN002 125, 250, 375, or 500 mg were applied every 12 hours. After a 4-week baseline period, the children were treated with ZYN002 at a twice daily dose of 125mg (< 25kg) or 250mg ( >25kg). Doses could be titrated up to a dose of 375mg (< 25kg) or 500mg ( >25kg) twice a day.

Primary outcomes were safety and median percent change from baseline in the monthly (28‐day) seizure frequency over 26 weeks. Caregivers used daily diaries to record the number of countable seizures by seizure type. Absence, myoclonic, and focal aware (non‐motor) seizures were also evaluated daily. Safety and tolerability assessments included adverse events, examination of skin, vital signs, and clinical laboratory test.

In the 26‐week treatment period, of the 48 participants (26 male) enrolled and analyzed for safety, 46 were evaluated for eﬃcacy.

Key findings of the study include:

60.4% patients had at least 1 treatment-related adverse event over 26 weeks, of which 93% were mild or moderate.
The most frequent were application site dryness, application site pain, and somnolence, each 8.3%.
The percentage of patients with a new onset drug-related adverse event decreased from 38% at Week 4 to 3% at Week 26.
In 33 patients with focal impaired awareness seizures and/or tonic-clonic seizures at baseline, there was up to 58% median monthly reduction in these seizure types from Week 8 to Week 26 and up to 63% of these patients experienced a ≥50% reduction in monthly seizure frequency during this time period.

"ZYN002 CBD transdermal gel was well tolerated and data suggest reduced seizure frequency in children and adolescents with a DEE. This positive benefit‐risk profile supports further study of ZYN002 in this difficult to treat population," concluded the authors.

ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Developmental and Epileptic Encephalopathies: An Open-Label Clinical Trial was presented at the AES 2020.

Article Source : AES 2020

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Medha Baranwal

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

CBD gel reduces seizures in children with DEE: BELIEVE trial

Similar News

Beyond Scores: Study Enhancing Neonatal Outcomes through APGAR Analysis

PFAS Exposure Linked to Weight Regain After Teen Bariatric Surgery: Study

Children Born Small for Gestational Age Face Higher Risk of Neurodevelopmental Disability by Age 5: Hokkaido Study

Obese Children Face Nearly 5-Fold Higher Risk of Fractures, Study Finds

Pediatric Pain Relief in Laparoscopic Surgery: Study Unravels Anesthetic Dilemma

New guidance to improve safety and outcomes of patent ductus arteriosus closure in premature infants, released by SCAI

Resilience: What protects infants from sudden infant death syndrome?

Strong Leg Muscles Linked to Lower Metabolic Syndrome Risk in Obese Youth: Study