CBD Transdermal Gel Reduces Seizure Frequency, nVNS Improves Migraine, EDSS Accuracy Improvised

December 26, 2020
NeurologyLive Staff

Neurology News Network for the week ending December 26, 2020.

This week Neurology News Network covered the results of the BELIEVE open-label trial which evaluated cannabidiol transdermal gel in developmental encephalopathies, as well as a study evaluating non-invasive vagus nerve stimulation in patients with migraine, and how the Expanded Disability Status Scale score can be more accurate with other tests incorporated.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

Results from the BELIEVE (ZYN2-CL-025) open-label clinical trial presented at the American Epilepsy Society (AES) Annual Meeting, December 4–8, 2020, show that ZYN002 cannabidiol transdermal gel was well tolerated and reduced seizure frequency in adolescents and children with developmental and epileptic encephalopathies (DEE) such as West Syndrome, Lennox-Gastaut Syndrome (LGS), and Dravet Syndrome (DS). 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. At least 1 treatment-related adverse event (TEAE) occurred over 26 weeks in 29 (60.4%) patients, of which 93% were mild or moderate. The most frequent TEAEs were application site dryness, application site pain, and somnolence, each with an 8.3% occurrence rate. Patients with a new onset drug-related adverse event decreased from 38% at Week 4 to 3% at Week 26.

electroCore announced that the results from the GM-US-10 (PREMIUM 2) study involving non-invasive vagus nerve stimulation (nVNS) met all end points, including several patient-assessed quality of life measures in patients with migraine. Despite the early termination of the study in April 2020 due to the COVID-19 pandemic, topline results showed benefits from nVNS, including multiple end points achieving a statistically significant improvement compared to sham stimulation. The company noted that the full publication of the results is expected to come sometime in early 2021. Within the mITT population, 44.9% of patients using gammaCore nVNS had at least a 50% decrease in the number of migraine days, compared to 26.8% of those who received sham stimulation. Additionally, there was a statistically significant decrease in migraine associated disability and an improvement in QOL across all QOL end points in those using the nVNS.

The accuracy of the Expanded Disability Status Score (EDSS) may be increased when cognitive changes during relapse activity are factored in from the Symbol Digit Modalities Test (SDMT) and the Fatigue Severity Score (FSS), according to results from a prospective study. Lead author Sarah A. Morrow, professor of neurology, Western University, and colleagues incorporated the SDMT into the cerebral Functional System Score (CFSS) of the EDSS in a cohort of 592 persons with multiple sclerosis (MS). They found that the m-CFSS was significantly higher than CFSS at baseline and relapse. Additionally, the m-EDSS was higher than EDSS at relapse, including 35 patients (43.8%) in the relapse group (RG) who had higher m-EDSS than EDSS at relapse. Morrow et al noted, “It is hoped that these findings will lead to further improvement in the clinical detection of relapses and cognitive change over time which can improve our ability to treat and support our MS patients.”

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