Cognitive effects of topiramate in migraine patients aged 12 through 17 years.
Neuropsychologic data are presented from a randomized, double-blind, placebo-controlled, multicenter study with placebo, topiramate 50 mg/day, and topiramate 100 mg/day. The Cambridge Neuropsychological Test Automated Battery (CANTAB) and cognitive adverse events were used to evaluate neurocognitive effects of topiramate. Topiramate 100 mg/day vs placebo was associated with slight statistically significant score increases, indicating slowing, from baseline vs placebo in three CANTAB measures: five-choice reaction time (P = 0.028), pattern recognition memory mean correct latency (P = 0.027), and rapid visual information processing mean latency (P = 0.040). No other patterns related to topiramate treatment were observed in measurements of learning, memory, and visual information processing, except for potential improvement with topiramate 100 mg/day vs placebo in spatial span total errors (accuracy test) (P = 0.040). The most common cognitive and neuropsychiatric adverse events with a higher incidence in the topiramate 50 and 100 mg/day groups vs placebo were anorexia (9% and 11% vs 3%), insomnia (9% and 3% vs 3%), fatigue (6% and 9% vs 6%), and dizziness (6% and 9% vs 0%). Thus, topiramate 100 mg/day was associated with modest increases in psychomotor reaction times. Learning, memory, and executive function were unchanged. The tolerability profile, including cognitive adverse events, appeared to be acceptable.
Psychiatry, Johnson & Johnson Pharmaceutical Research & Development L.L.C, Titusville, New Jersey 08560, USA. gpandina@its.jnj.com
Gahan J
GJ
Pandina
Seth
S
Ness
Elena
E
Polverejan
Eric
E
Yuen
Marielle
M
Eerdekens
Robert M
RM
Bilder
Lisa
L
Ford
D000293:Adolescent; D000855:Anorexia / Q000139:chemically induced / Q000453:epidemiology; D002648:Child; D003072:Cognition Disorders / Q000139:chemically induced* / Q000175:diagnosis*; D004244:Dizziness / Q000139:chemically induced / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy*; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D009483:Neuropsychological Tests; D011930:Reaction Time / Q000187:drug effects; D021641:Recognition, Psychology / Q000187:drug effects; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced / Q000453:epidemiology; D013028:Space Perception / Q000187:drug effects; D000077236:Topiramate; D014796:Visual Perception / Q000187:drug effects
D018696:Neuroprotective Agents; D000077236:Topiramate; D005632:Fructose