Matt Hoffman

The oral, dual-mechanism therapy from Axsome Therapeutics met both of its primary end points in the phase 3 MOMENTUM trial in acute migraine, and is expected to be filed with the FDA.

Catch up on some of our most popular Peer Exchange panels with experts in the field, including discussions on epilepsy, migraine, multiple sclerosis, and more.

After promising results in prior phase 2 study, Stealth BioTherapeutics’ elampretide has failed to show change in the 6-minute walk test and Primary Mitochondrial Myopathy Symptom Assessment total fatigue score in the MMPOWER-3 trial.

The behavioral director at the Angelman Syndrome Clinic at Massachusetts General Hospital offered insight into the challenges in studying a drug, such as gaboxadol, in Angelman syndrome.

The second of 2 identical trials investigating 2 doses of low-dose fenfluramine (Fintepla) is set to be completed in early 2020, as the agent awaits FDA approval.

Branded as Ubrelvy, Allergan’s oral calcitonin gene-related peptide antagonist is the first-in-class to be approved for this indication.

Panelists review the delicate process of introducing a new medication to a treatment regimen and the creative endeavors employed to improve adherence.

The behavioral director at the Angelman Syndrome Clinic at Massachusetts General Hospital discussed the phase 3 NEPTUNE trial of gaboxadol, also known as OV101.

After resubmitting the NDA for apomorphine sublingual film (APL-130277), the FDA has set the new PDUFA action date of May 21, 2020.

Compared to counterparts who did not exercise, those with cognitive impairments with no dementia risk factors improved in executive functioning when they exercised consistently over 6 months.

The third generation, high-affinity, selective small molecule CGRP receptor antagonist was significantly superior in the 2 higher doses on both co-primary end points of pain freedom and most bothersome symptoms.

Given the data, Adamas has stated that it will forgo its originally planned second phase 3 placebo-controlled study, instead continuing its open-label extension study and engaging the FDA to discuss ADS-5102’s regulatory pathway.

The CEO and Chairman of the Board of Directors at INSIGHTEC offered his perspective on how technologies such as focused ultrasound can help shape the future of neurologic care.

The study reported that those with MS who breastfed experienced 43% lower rates of postpartum relapse compared to those who did not.

The CEO of INSIGHTEC offered insight into what challenges in the neurologic space the company plans to tackle in the coming years, and why 2020 marks the start of the “Century of the Brain.”

Intra-arterial urokinase improved Thrombolysis in Cerebral Infarction (TICI) scale scores and independence at 90 days, without increasing the risk of symptomatic intracranial hemorrhage.

Treatment with the calcitonin gene-related peptide (CGRP) inhibitor resulted in significant improvements in monthly migraine headache days across the groups assessed, including a significantly greater number of patients with ≥50% and ≥75% reductions.

After receiving expedited review after receiving a Complete Response Letter in August, the therapy was approved based on data showing a statistically significant increase in dystrophin production in skeletal muscle.

Patients treated with NeuroPace’s Responsive Neurostimulation system within 20 years of epilepsy onset were observed to have significantly better outcomes related to several aspects of quality of life and mood compared to those treated later.

Study findings suggest that the presence of hypsarrhythmia—abnormal, chaotic brainwave patterns—may play a role in the risk of autism spectrum disorder in patients with a history of infantile spasms.

In a PROVE study subgroup of adolescent patients exposed to perampanel over a 2-year period, the Eisai product proved to be well-tolerated and efficacious, with good retention rates.

Interim analysis of a 5-year, post-approval study of the NeuroPace Responsive Neurostimulation system support prior findings that the device is safe and effective in reducing medically intractable focal seizures in adults.

A single-center study of more than 3600 virtual visits displayed a high level of satisfaction from patients regarding their experience with telemedicine and their providers, suggesting the practice may be ready for large-scale use.

Despite evidence of the benefits and safety of breastfeeding in women with epilepsy, 2 studies suggest this population breastfeeds significantly less often than women without epilepsy, due to fears of drug exposure or recommendations against the practice.

Patients who were treated with cannabidiol 25 mg or 50 mg experienced seizure reductions of 49% and 48%, respectively, nearly double that of the placebo group, which experienced reductions of 27%.

In light of the public health implications of speedier stroke treatment, these data suggest that mobile stroke units could represent a potentially beneficial addition to stroke systems of care in dense cities.

The FDA granted approvals to HEC Pharm Co. Limited, Biocon Limited, and Sun Pharmaceutical Industries Limited, for their generic formulations of Novartis’ product, branded as Gilenya, for the treatment of relapsing forms of multiple sclerosis.

The data presentation from the phase 3 EMERGE and ENGAGE clinical trials suggest that aducanumab may result in disease-modifying effects, slowing clinical decline in those with early Alzheimer disease. Biogen expects to submit a BLA to the FDA for approval in early 2020.

Fenfluramine reduced monthly convulsive seizure frequency by 54% compared with placebo in patients on medication regimens including stiripentol, with a significant proportion of those experiencing a meaningful or profound reduction.

Within the first 2 years of DBS treatment, patients with Parkinson experienced improvements in freezing of gait and other axial signs in off periods compared to best medical treatment.