Clardibine Approved for Relapsing, Secondary Progressive MS, Cervella Cranial Electrotherapy Approved for Insomnia, and Management of Stroke With Tandem Occlusion
Neurology News Network for the week of April 6, 2019.
PUBLISHED April 06, 2019
This week, Neurology News Network covered the FDA approval of cladribine for relapsing multiple sclerosis, as well as active secondary progressive multiple sclerosis, the FDA market clearance for Innovative Neurological Device's Cervella Cranial Electrotherapy medical device to treat insomnia, and the need for a randomized clinical trial to better understand the benefits of acute stenting of the internal carotid artery. (Transcript below)
Welcome to Neurology News Network. I’m Jenna Payesko.Let’s get into the news from this week.
The FDA has approved cladribine, marketed as Mavenclad by EMD Serono, as an oral therapy for the treatment of relapsing multiple sclerosis, as well as active secondary progressive MS. The treatment is not recommended for use in patients with clinically isolated syndrome.
The approval was based on data from a trial that included more than 1300 patients with relapsing forms of MS, ultimately showing a significant decrease in the number of relapses experienced by patients who had greater than or equal to 1 relapse in the previous year, compared with placebo.
According to the FDA, the treatment must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks, which includes a Boxed Warning for an increased risk of malignancy and fetal harm.
This is the first cranial electrotherapy stimulator with propriety conductive treatment electrodes integrated into ear pads of over-ear noise-canceling Bluetooth-enabled headphones, which can be used during treatment.
Acute management of tandem occlusion in stroke varies greatly, according to results of an international survey, emphasizing the need for a randomized clinical trial to better understand the benefits of acute stenting of the internal carotid artery.
Lead author Dr. Gregory Jacquin told NeurologyLive that “the survey was conducted because we are facing a large number of patients suffering acute stroke from a carotid stenosis and who undergo thrombectomy in our own center. We are regularly facing the dilemma whether or not to treat the carotid that caused the stroke in the same treatment session or not since no dedicated studies have been undertaken that prospectively evaluate the risk-benefit ratio of acute carotid stenting in patients undergoing acute stroke thrombectomy.”
For more direct access to expert insight, head to neurologylive.com. This has been Neurology News Network. Thanks for watching.