RBD Shows No Impact Post-DBS, Erenumab Superior to Topiramate, ADORE Phase 3 Trial Begins

Neurology News Network for the week ending November 13, 2021.

This week Neurology News Network covered the effects of preoperative RBD on patients with Parkinson disease who undergo deep brain stimulation, the benefits seen in erenumab over topiramate, and the recently announced phase 3 trial of FNP122 in 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.

Data from a multicenter, prospective study in France showed no between-group differences for patients with Parkinson disease (PD) with or without preoperative REM sleep behavior disorder (RBD) on cognitive, psychobehavioral, and global quality of life outcomes, a year after undergoing subthalamic deep brain stimulation. A total of 215 patients with PD from the PREDISTIM cohort who had 12-month follow-up after STN-DBS were analyzed to answer whether RBD is a risk factor for poorer motor, nonmotor and quality of life outcomes. Of them, 122 (57%) had probable preoperative RBD (preopRBD+) while 93 (43%) were preopRBD-. Investigators found comparable mean decreases in Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III scores of 52% in preopRBD+ and by 54% in preopRBD-. Additionally, they found decreases of 37% and 33% on MDS-UPDRS IV scores, further highlighting the lack of between group difference.

Newly announced data from HER-MES, a first of its kind comparator study, showed significantly lower discontinuation rates due to adverse events (AEs) as well as superior efficacy in reducing monthly migraine days (MMDs) for patients with episodic and chronic migraine when treated with erenumab (Aimovig; Novartis) as opposed to topiramate. This 24-week, randomized, double-blind, double-dummy, controlled trial was the first and only head-to-head study of erenumab, the first FDA-approved CGRP inhibitor, against topiramate, one of the most-prescribed migraine prevention medications. A total of 777 patients with at least 4 migraine days per month were randomly assigned 1:1 to either subcutaneous erenumab (70 or 140 mg/month) plus topiramate placebo or oral topiramate at the individual dose with optimal efficacy (50-100 mg/day) plus erenumab placebo.During the double-blind treatment period, 10.6% (41 of 388) of patients in the erenumab group discontinued medication due to AEs, compared to 38.9% in the topiramate group, with an OR of 0.19 and a relative risk (RR) of 0.27. In total, 26.6% of the topiramate group aborted medication by the end of week 6, whereas only 8.3% of those on erenumab ended their treatment.

The first patient with amyotrophic lateral sclerosis (ALS) has been enrolled in the ALS Deceleration with Oral Edaravone (ADORE) phase 3 trial of FNP122, an oral formulation of edaravone, Ferrer Pharma announced. The trial is set to enroll approximately 300 patients throughout Europe to evaluate the safety, survival, and efficacy of FNP122. TRICALS, a European research initiative aimed at finding a cure for ALS, has supported the phase 3 trial. In the statement, Leonard H. van den Berg, MD, chair, TRICALS; professor of neurology, University Medical Centre Utrecht, and principal investigator of the ADORE study expressed the consortium’s pride in the collaboration with Ferrer, calling the study “important,” and adding that the group “look[s] forward to offering further support throughout the course of the trial. We hope oral edaravone will yield a positive outcome and be beneficial for people diagnosed with ALS, as more effective treatment is available”.

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