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NCT02550028

Levetiracetam Treatment of Neonatal Seizures

Terminated Phase 1, PHASE2 Last updated 29 December 2023
What this trial tests

Phase 1, PHASE2 trial testing Oral levetiracetam in Neonatal Seizures in 60 participants. Terminated before completion.

Timeline
1 September 2015
Primary endpoint
1 January 2017
1 January 2017

Quick facts

Lead sponsorChildren's Hospital of Fudan University
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment60
Start date1 September 2015
Primary completion1 January 2017
Estimated completion1 January 2017
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital of Fudan University

Who can join

Under 28 Days, any sex, with Neonatal Seizures. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. A multi-centre Chinese clinical trials with the aim to using oral Levetiracetam to develop new treatment strategies for the treatment of neonatal seizures. The purpose of this study is to determine the correct oral dosing, safety and efficacy for oral Levetiracetam as first line treatment in term new born babies with seizures.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Treating the symptom or treating the disease in neonatal seizures: a systematic review of the literature.
    Falsaperla R, Scalia B, Giugno A, Pavone P, et al · · 2021 · cited 15× · PMID 33827647 · DOI 10.1186/s13052-021-01027-2
  2. Anti-seizure medications for neonates with seizures.
    Abiramalatha T, Thanigainathan S, Ramaswamy VV, Pressler R, et al · · 2023 · cited 12× · PMID 37873971 · DOI 10.1002/14651858.cd014967.pub2

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Other trials of Oral levetiracetam

Trials testing the same drug.

Other Children's Hospital of Fudan University trials

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