Migraine Preventive Prescription Trends, TAK-861 Phase 1 Study in Narcolepsy, Simufilam Not Associated With ARIA-E

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Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Data from a recently published, multicenter, retrospective cohort study showed that approximately two-fifths of young adults aged 18 to 25 years old were prescribed preventive medications for migraine, with similar prescription rates between pediatric and adult neurologists. The analysis included 767 patients who had a diagnosis of migraine between 2017 and 2021 at an outpatient visit to a Mass General Brigham (MGB) neurologist. Of these, 290 (37.8%) were seen by a pediatric neurologist and 477 (62.2%) seen by an adult neurologist. Preventive medications were prescribed in 43.9% (n = 337) of the total population, with 45.2% and 43.2% of those seen by pediatric and adult neurologists, respectively, getting prescriptions.

A new data analysis from a phase 1, randomized, double-blind, placebo-controlled, 3-period cross-over study showed both high and low doses ofTAK-861 (Takeda) had significant and dose-dependent improvements in wakefulness compared with placebo among healthy adult men, with no serious or severe adverse events.1 These findings suggest that TAK-861, an oral highly selective OX2R agonist, may potentially be a safe and effective therapy for patients with narcolepsy who experience excessive daytime sleepiness. In the analysis, both high (30mg; 10mg) and low doses (15mg; 5mg) of the regimen significantly improved measures of sleepiness in participants. The least square (LS) mean differences from placebo in maintenance of wakefulness test mean sleep latency were 17.8 minutes and 19.1 minutes for TAK‑861 low and high doses, respectively.

Interim data from REFOCUS-ALZ, a global phase 3 study, showed that treatment with simufilam (Cassava Sciences), an investigational agent in development for Alzheimer disease (AD), was not associated with amyloid-related imaging abnormality (ARIA)-edema emergence. Final MRI data is expected at the conclusion of the study. In this volumetric MRI substudy, MRI protocol was conducted on 1.5T and 3T scanners and consisted of 3DT1, FLAIR, T2 and DWI sequences. Results showed that most of the cohort (n = 160; 88%) had no clinically significant findings at week 40 while a small portion of patients (n = 13; 7%) had clinically significant findings identified at screening that persisted to week 40. These included infarcts, uni- and multi-focal cortical superficial siderosis (CSS), and other infrequent abnormalities.

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