Drugs / Keppra
last change Feb 2020 re-read 3 minutes ago

Keppra

Developed for
cervical dystonia · Alzheimer disease · epilepsy · epilepsy with generalized tonic-clonic seizures
Investigated by
University of South Florida

Regulatory milestones approvals, filings & regulatory actions · 10 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (8) US (FDA) KEPPRA — 2005-06-21 – 2019-10-23 fda.gov ↗
Approved EU (EMA) Keppra — 2000-09-29 europa.eu ↗
Approved US (FDA) KEPPRA — 1999-11-30 fda.gov ↗

Trials 1

today
US approved 1999
EU approved 2000
NCT00760318 · Ph 2
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT00760318 Nov 2005 → Oct 2007 cervical dystonia University of South Florida Terminated No outcome recorded Stop: Enrollment
Comparator or background therapy4 trials
Phase 4 NCT00510783 Comparator Jul 2007 → Dec 2008 epilepsy with generalized tonic-clonic seizures Emory University Completed No outcome recorded
— NCT01685411 Background Jan 2013 → Feb 2020 acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome Masonic Cancer Center, University of Minnesota Terminated No outcome recorded
— NCT01666080 Background Aug 2012 → Jun 2027 expected hemoglobinopathy, immunodeficiency disease Masonic Cancer Center, University of Minnesota Recruiting No outcome recorded
— NCT01554683 Comparator Feb 2012 → Jul 2017 Alzheimer disease, epilepsy Beth Israel Deaconess Medical Center Completed No outcome recorded

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as Keppra “Drug: Keppra” NCT01666080 ↗
4

NCT01554683 ↗

NCT00760318 ↗

NCT01685411 ↗

NCT00510783 ↗

Route Intravenous “Patients in the intervention arm will receive IV Keppra” NCT00510783 ↗