Emergency treatment with levetiracetam or phenytoin in status epilepticus in children (EcLiPSE) - a randomsied unblinded controlled trial

Phase 1

• Conditions: Convulsive Status Epilepticus; MedDRA version: 18.1 Level: LLT Classification code 10057955 Term: Convulsive status epilepticus System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-002188-13-GB
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-20
• Study Completion: 2018-05-21
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 286

Inclusion Criteria

1. Males and females aged 6 months to 18 years (<18th birthday).
2. Presenting seizure is generalised tonic-clonic, generalised clonic or focal clonic status epilepticus that requires second-line treatment to terminate the seizure.
3. First-line treatment administered according to APLS guidelines or the child’s personalised rescue care plan in order to try and terminate the presenting seizure.

Eligibility Notes

• APLS guidelines:
Guidelines classify two doses of benzodiazepines as first-line treatment. If patients are given more than two doses of benzodiazepines then they are still eligible.

• Personalised rescue care plan:
Patients whose personalised rescue care plan includes rectal paraldehyde as the first-line treatment are still eligible.

• Maintenance anti-epileptic medication:
Patients receiving oral phenytoin or levetiracetam as part of their regular oral anti-epileptic drug regime are still eligible for this trial.

Are the trial subjects under 18? yes
Number of subjects for this age range: 308
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Absence, myoclonic or non-convulsive status epilepticus, or infantile spasms.
2. Known or suspected pregnancy.
3. Known contra-indication or allergy to levetiracetam or phenytoin. This includes where the child’s personalised rescue care plan states that the child never responds to, or has previously experienced a severe adverse reaction to, phenytoin, levetiracetam, or both.
4. Known renal failure (patients on peritoneal or haemodialysis or with renal function <50% expected for age)
5. Previous administration of a second-line antiepileptic drug prior to arrival in the emergency department.
6. Known to have previously been treated as part of EcLiPSE.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified