Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure

NCT07220902 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 1559
• Study Type: interventional
• Target: 1,240
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare levetiracetam to magnesium sulfate for the prevention of eclamptic seizures in pregnant persons with severe preeclampsia that are 32 or more weeks pregnant. This is an equivalence study so our primary goal is to see no difference in the incidence of seizure in the two groups. Since side effects can be a significant problem with magnesium sulfate and these patients are at significant risk of life threatening complications, we also plan to evaluate several secondary outcomes in the mothers and the babies, including: severe allergic reaction, magnesium toxicity, ICU admission, hospital readmission, transfusion for any reason, pulmonary edema, cardiomyopathy, Posterior Reversible Encephalopathy Syndrome, eclamptic seizure, loss of vision, stroke, renal injury requiring dialysis, cardiac arrest, maternal death, unexpected stillbirth or neonatal death, NICU admission, Apgars and length of neonatal respiratory support.

Conditions

Severe Preeclampsia; Eclampsia Preeclampsia

Keywords

Seizure; Prophylaxis; Preeclampsia; Eclampsia; Keppra; Levetiracetam; Magnesium; LEVMag; Equivalence

Outcome Measures

Primary Outcomes (1)

• Eclamptic Seizure

  Seizure based on clinical diagnosis by managing physician. It will be considered and eclamptic seizure for purposes of the study if it occurs following enrollment in the study.

  From enrollment until then end of monitoring at 6 weeks postpartum.

Study Arms (2)

Levetiracetam Arm

EXPERIMENTAL

This experimental arm will receive oral levetiracetam 3 times daily after an initial loading oral dose.

Drug: Levetiracetam

Magnesium Sulfate Arm

ACTIVE COMPARATOR

This arm will receive standard treatment- a loading dose of magnesium sulfate followed by a continuous infusion that is the current standard of care (4 gram bolus followed by 2grams per hour continuous infusion).

Drug: magnesium sulfate

Interventions

Levetiracetam DRUG

1g oral loading dose followed by 300mg q 8 hours beginning 8 hours after loading dose.

Also known as: Keppra

Levetiracetam Arm

magnesium sulfate DRUG

4gram bolus followed by 2g per hour continuous infusion

Magnesium Sulfate Arm

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Birthing persons are the only population that can be included as the study is being conducted in pregnancy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant or postpartum women aged 19 years or older
• Diagnosed with preeclampsia with severe features, superimposed preeclampsia or HELLP syndrome
• At risk for eclampsia and eligible for seizure prophylaxis
• Less than 2 hours exposure to magnesium sulfate or greater than 48 hours since last dose.
• Admitted or plan to proceed with delivery

You may not qualify if:

• \<32 weeks estimated gestational age
• History of epilepsy or seizure disorders unrelated to pregnancy
• Allergy or contraindication to Levetiracetam or Magnesium Sulfate
• Severe renal impairment (Oliguria \<120ml in 4 hours)
• Plan for neonatal comfort care

Sponsors & Collaborators

• Nebraska Methodist Health System: lead

Study Sites (1)

Methodist Women's Hospital

Omaha, Nebraska, 68022, United States

Location

Related Publications (18)

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MeSH Terms

Conditions

Pre-Eclampsia; Seizures; Eclampsia

Interventions

Levetiracetam; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Todd Lovgren, MD

  Nebraska Methodist Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Todd Lovgren, MD

CONTACT

1+402-815-1970; todd.lovgren@nmhs.org

Joshua Dahlke, MD

CONTACT

1+402-815-1970; joshua.dahlke@nmhs.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): July 1, 2034
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be shared beginning 1 year after publication.
• Access Criteria: Deidentified IPD will be shared on a case by case basis with principal investigators by contacting the PI for this study.

Locations

US (1)