NCT00175890 - 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)

Piña-Garza JE, Nordli DR Jr, Rating D, Yang H, Schiemann-Delgado J, Duncan B; Levetiracetam N01009 Study Group
Adjunctive levetiracetam in infants and young children with refractory partial-onset seizures. Epilepsia. 2009 May;50(5):1141-9. doi: 10.1111/j

A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age

Details for clinical trial NCT00175890

Clinical trial NCT00175890 - References