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Treatment with ubrogepant (Allergan, Madison, NJ) resulted in similar magnitudes of pain relief for participants who had triptan-nonreponsive migraine (n ~1,000), triptan-responsive migraine, or who were naïve to triptan treatment. Individuals in the triptan-nonresponsive group included primarily people for whom triptans had been ineffective (~80%), with some having intolerability to triptans (~17%) and a few having contraindications (~3%). Treatment-emergent adverse events were not serious and were also similar amongst the 3 groups and those who took placebo. In the ACHIEVE II...
The Food and Drug Administration (FDA) has approved amifampridine (Ruzurgi; Jacobus Pharmaceutical Company, Princeton, NJ) for treating Lambert-Eaton myasthenic syndrome (LEMS) in patients age 6 to 17 years. This is the first FDA approval of a therapy specifically for pediatric patients with LEMS, a rare autoimmune neuromuscular junction disorder. Use of amifampridine in pediatric patients is supported by clinical studies in adults with LEMS, pharmacokinetic data in adult patients, pharmacokinetic modeling and simulation to identify the dosing regimen in pediatric...
The nasally administered benzodiazepine spray midazolam (Nayzilam; UCB, Smyrna, GA) has been approved by the Food and Drug Administration (FDA) for acute treatment of frequent seizure activity in people age 12 and up with epilepsy. The nasal spray is a single-use treatment that can be administered when a seizure cluster occurs. Midazolam is the first new medication approved for treating seizure clusters in more than 20 years in the US. In a randomized double-blind clinical trial (NCT01390220), a statistically significant higher proportion of seizure episodes treated with midazolam (n = 134)...
Niushen Zhang, MD
Rashmi B. Halker Singh, MD; Amaal J. Starling, MD; and Juliana VanderPluym, MD
Umer Najib, MD, FAHS; Jessica Frey, MD; and David B. Watson, MD, FAHS, FAAN