NCT01239212 is a Phase 1/Phase 2 clinical trial of levetiracetam in Seizures, sponsored by Children's Hospital Medical Center, Cincinnati.

Who is sponsoring NCT01239212?

NCT01239212 is sponsored by Children's Hospital Medical Center, Cincinnati.

What drugs are being tested in NCT01239212?

Interventions in NCT01239212: levetiracetam.

Is NCT01239212 still recruiting?

NCT01239212 is currently completed. Last updated 11 August 2021.

Are results published for NCT01239212?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-08-11 · How we verify

NCT01239212

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates

Completed Phase 1/Phase 2 Results posted Last updated 11 August 2021

What this trial tests

Phase 1/Phase 2 trial testing levetiracetam in Seizures in 7 participants. Completed in 1 July 2011.

Timeline

1 September 2010

Primary endpoint
1 July 2011

1 July 2011

Quick facts

Lead sponsor	Children's Hospital Medical Center, Cincinnati
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	1 September 2010
Primary completion	1 July 2011
Estimated completion	1 July 2011
Sites	1 location across United States

Drugs / interventions tested

levetiracetam (levetiracetam) — full drug profile →

Conditions studied

Seizures — all drugs for Seizures →

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Adults 1 Day to 30 Days, any sex, with Seizures. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Pharmacokinetic Profile
Time frame: 5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)
3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by

Sponsor's own description

The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of levetiracetam

Trials testing the same drug.

NCT03196466 — Population Pharmacokinetics of Antiepileptic in Pediatrics · completed
NCT02002819 — Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability · Phase 2 · completed
NCT01857934 — Therapy for Children With Advanced Stage Neuroblastoma · Phase 2 · completed
NCT01345058 — Add on Lacosamide Versus High Dose Monotherapy · Phase 3 · completed

Other recruiting trials for Seizures

Currently open trials in the same condition.

NCT07072624 — Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial) · Phase 4 · recruiting
NCT06714448 — A Study of the Effectiveness of Risk Minimization Measures Related to Depakine® (Sodium Valproate) in Saudi Arabia · active not recruiting
NCT07136298 — Seizure Identification on the Intensive Care Unit (ICU) · recruiting
NCT06442748 — Short Versus Long-term Levetiracetam in Brain Tumors · Phase 3 · recruiting
NCT06401707 — PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest · Phase 2 · recruiting

Other Children's Hospital Medical Center, Cincinnati trials

Trials by the same sponsor.

NCT07430332 — GLP-1 RA for Stage 1 Type 1 Diabetes · Phase 2 · not yet recruiting
NCT07077213 — 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients · recruiting
NCT07265141 — An Automated Virtual Reality Intervention to Enhance Firearm Safety Counseling in Pediatrics · NA · not yet recruiting
NCT07217444 — Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation · NA · recruiting
NCT07195123 — Evaluation of the SMART IBD App in Pediatric IBD · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01239212 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati
Last refreshed: 11 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01239212.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing