Lemborexant Shows Positive Medication Effect, New Comparative Study for CGRPs Announced, Ultra-Early Epilepsy Surgery Effective


Neurology News Network for the week ending July 2, 2021.

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.

New 12-month data from Study 303 suggest that the majority of patients with insomnia who were treated with lemborexant report experiencing a positive medication effect.1 These findings extend previous results from the study suggesting as much through 6 months of treatment.At month 9, more than 70% of those in both treatment arms reported that the therapy helped them sleep, with similar results at month 12. Additionally, the majority of patients reported that lemborexant increased total sleep time at both month 9 and month 12. Christopher Drake, section head of Sleep Research at Henry Ford Hospital said in his presentation, “The-se findings provide an understanding of how a patient’s overall experience of medication effects corresponds to changes in sleep parameters measured by sleep diary and may be useful to clinicians in determining whether a treatment regimen is providing the expected benefit.”

Eli Lilly recently announced a phase 4 study comparing its once-monthly injectable galcanezumab (Emgality), a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb), to Biohaven’s rimegepant (Nurtec ODT), an orally disintegrating CGRP receptor antagonist. Enrollment for the study is expected to begin later this year.Galcanezumab binds to the GCRP protein, preventing it from attaching to the CGRP receptors, whereas rimegepant blocks the receptor for this protein. The study, which is the first head-to-head clinical trial comparing 2 medications targeting CGRP, will aim to answer important questions that will help clinicians and patients make more informed treatment decisions, according to Eli Lilly. The multisite, randomized, double-blind, double-dummy, parallel-group study will use 50% reduction in monthly migraine headache days as the primary end point. Patients with a diagnosis of episodic migraine with or without aura will be treated with either 120-mg galcanezumab once-monthly injection with an initial 240-mg loading dose, or 75-mg rimegepant taken every other day.

Data from a multinational, multicenter, retrospective study evaluating epilepsy surgery for infants with drug-resistant epilepsy (DRE) younger than 3 months of age found that the procedure is associated with excellent seizure control and is not associated with more permanent morbidity than surgery in older infants. To build upon limited literature regarding such “ultra-early” epilepsy surgeries, investigators collected data on 64 patients who underwent 69 surgeries before the age of 3 months. Excellent seizure outcome, measured as International League Against Epilepsy (ILAE) grade 1, was achieved in 66% of cases over a median follow-up of 41 months. While there was a slightly higher percentage of patients who had excellent seizure outcome using hemispheric surgery compared to focal, investigators deemed that there was no significant correlation between ILAE grade and the type of surgery.

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