NCT00160550 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Berkovic SF, Knowlton RC, Leroy RF, Schiemann J, Falter U; Levetiracetam N01057 Study Group
Placebo-controlled study of levetiracetam in idiopathic generalized epilepsy. Neurology. 2007 Oct 30;69(18):1751-60. Epub 2007 Jul 11.
Rosenfeld WE, Benbadis S, Edrich P, Tassinari CA, Hirsch E
Levetiracetam as add-on therapy for idiopathic generalized epilepsy syndromes with onset during adolescence: analysis of two randomized, double-blind, placebo-controlled studies. Epilepsy Res. 20

A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With 3000 mg/Day (Pediatric Target Dose of 60 mg/kg/Day) Oral Levetiracetam (LEV) (166, 250, and 500mg Tablets), in Adult and Pediatric Subjects (4-65 Years) Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic (PGTC) Seizures.

Details for clinical trial NCT00160550

Clinical trial NCT00160550 - References