PGTC

AcronymDefinition
PGTCPrimary Generalized Tonic-Clonic (seizure)
PGTCPrairie Grove Telephone Company (Prairie Grove, AR)
PGTCPair Gain Test Controller
PGTCPrairie Grouse Technical Council (research group; Nebraska)
References in periodicals archive ?
Fycompa has also been approved in more than 35 countries, including Japan, the United States, and in Europe for the adjunctive therapy of PGTC seizures in patients with epilepsy 12 years of age and older.
In the larger study, 117 children, adolescents, and adults with EEG-confirmed PGTC seizures who were taking one or two concurrent antiepileptic drugs who also experienced three or more PGTC seizures during an 8-week baseline phase were randomized to adjunctive treatment with lamotrigine (58) or placebo (59).
In the posthoc subgroup analysis looking at only the results for adolescents and children--21 of whom were randomized to lamotrigine and 24 who got placebo--lamotrigine reduced the number of PGTC seizures from baseline by 77% during the entire treatment period compared with 40% for placebo.
Fycompa has been also been approved in more than 35 countries, including Europe and the United States, for the adjunctive therapy of PGTC seizures in patients with epilepsy 12 years of age and older.
The FDA's decision to approve the indication expansion was based on a placebo-controlled clinical phase III study (Study 332) of Fycompa in 164 patients aged 12 years and older with PGTC seizures.
Applications seeking an additional indication for the adjunctive treatment of PGTC seizures in patients with epilepsy aged 12 years and older based on the results of this study were filed with regulatory authorities in Europe and the United States in August 2014.
Study 332 was a double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive Fycompa therapy in 164 patients aged 12 years and older with uncontrolled PGTC seizures.