Safety and effectiveness established in patients 12 17 years. Efficacy on migraine associated symptoms (nausea, photophobia and phonophobia) was not established. Safety and effectiveness in pediatric patients < 12 years have not been established The most common adverse events were dizziness, somnolence, headache, paresthesia, nausea and vomiting. Safety and tolerability similar to adults. Information on dosing, adverse events, PK parameters, clinical study Patient population altered
|