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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 scheduled an end-of-phase 2 clinical trial meeting for a sublingual formulation of racemic ketamine (Wafermine; iX Biopharma, Singapore) for treatment of moderate-to-severe acute pain. The therapy contains R and S isomers of ketamine in equal proportions In a phase 2b randomized placebo-controlled study (NCT03246971) participants experienced analgesic efficacy from ketamine with safety and tolerability for treatment of acute post-operative pain after abdominoplasty or bunionectomy. In pharmacokinetic studies (NCT01377831),...
Over 7,500 individuals have been or are being treated with nusinersen (Spinraza; Biogen, Cambridge, MA). Across clinical trials and the real-world setting, there are now 7 years of data and experience showing that nusinersen has clinical efficacy and safety. In the NURTURE study (NCT02386553) in which presymptomatic infants likely to develop spinal muscular atrophy type one (SMA1) or type 2 (SMA2) were treated with nusinersen, children continue to develop and gain typical motor milestones. After 26 months of treatment, all infants could sit without support; 88% could walk with support and 77%...
Emmanuelle A. D. Schindler, MD, PhD; and Christopher Gottschalk, MD
Ronald Devere, MD, FAAN
Katharine Nicholson, MD