Smartphone PMR Treats Migraine, NMOSD Relapse in Pregnant Women, FDA Grants ALS Agent Orphan Drug Designation

December 5, 2020
NeurologyLive Staff

Neurology News Network for the week ending December 5, 2020.

This week Neurology News Network covered a study that evaluated smartphone-delivered progressive muscle relaxation, neuromyelitis optica spectrum disorder on pregnant women, and the orphan drug designation of SLS-005 in patients with amyotrophic lateral sclerosis

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 a pilot study suggest that smartphone-delivered progressive muscle relaxation may be an acceptable and accessible form of therapy for patients with migraine after showing a small-moderate mean effect size in disability scores.The non-blinded, randomized, parallel-arm, controlled trial featured 139 participants with migraine with ≥4 headache days/month who were given the RELAXaHEAD smartphone application which includes an electronic headache diary over the 90-day study period. The app was developed in part by NYU School of Medicine researchers. The app’s PMR intervention includes a 5-minute (short) session and 15-minute (long) session as well as back-end analytics to capture time spent engaging with the app. Investigators noted that previously reported data from a single-arm study of the feasibility of RELAXaHEAD showed that people with migraine in a tertiary care neurology practice were willing to practice PMR for up to 6 weeks and that there may be a dose-dependent relationship in effect of the PMR.

A study that evaluated women with neuromyelitis optica spectrum disorder (NMOSD) during stages of pregnancy and post-pregnancy revealed that the first trimester post-partum is a high-risk period for relapse recurrence. Lead author Liang Wang, PhD, department of neurology, Shanghai Medical College, Fudan University, and colleagues also found that patients with younger age, higher aquaporin-4 antibody (AQP4-ab)-positive titer and inadequate treatment are at higher risk for pregnancy-related attack as well. Annualized relapse rate (ARR) was compared 12 months before pregnancy with every trimester of pregnancy and after delivery/abortion. There were significant increases during the first trimester after delivery or abortion compared with that before pregnancy.

The FDA has granted an orphan drug designation (ODD) to Seelos Therapeutics’ drug SLS-005 (Trehalose) for the treatment of amyotrophic lateral sclerosis (ALS), or Lou Gehrig disease.The therapy is believed to impact autophagy through Transcription Factor EB (TFEB), which plays a key role in lysosomal and autophagy gene expression, and thus increase clearance of the protein aggregates that build up in motor neurons of patients with ALS, such as TDP-43, SOD1, and SQSm1/p62. Warren W. Wasiewski, MD, FAAP, chief medical officer, Seelos, addressing planned trials in a statement, said, “Several preclinical studies have demonstrated the potential of trehalose as a treatment for ALS, demonstrating preservation of motor neurons, motor function and prolonged survival. We are excited to start our clinical program for this devastating disease.”Seelos will conduct a 24-week phase 2b/3 trial of 160 patients with either familial or sporadic ALS in a double blind, placebo-controlled trial. Change will be measured from baseline to 24 weeks using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R). Slow vital capacity, muscle strength, quality of life measurements, and other signs of disease progression will be studied.

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