A phase III trial shows a benefit, leading to the first FDA approval of a treatment for PBA.
Pseudobulbar affect (PBA), a severe outburst of emotional expression incongruous to a patient's emotional state, can occur in patients with amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and several other neurological disorders. PBA occurs in 20% to 50% of patients with ALS and 5% to 10% of those with MS. In this phase III, 12-week, blinded, placebo-controlled, manufacturer-supported study, researchers randomized 326 patients with PBA and either ALS or MS to receive high-dose dextromethorphan/quinidine (30 mg/10 mg), lower-dose dextromethorphan/quinidine (20 mg/10 mg), or placebo twice daily. (Patients with significant electrocardiographic [ECG] abnormalities were excluded.) The primary outcome measure was the change from bas…
Reviewing Author
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)