Levetiracetam vs Magnesium Sulfate for Preeclampsia

(LEVMag Trial)

Overseen By Joshua Dahlke, MD

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Nebraska Methodist Health System

Disqualifiers: Epilepsy, Seizure disorders, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36-96 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether levetiracetam, an experimental treatment, is as effective as the standard treatment, magnesium sulfate, in preventing seizures (sudden, uncontrolled electrical activity in the brain) in pregnant individuals with severe preeclampsia. Preeclampsia is a condition marked by high blood pressure and other serious symptoms. Participants will help researchers determine if levetiracetam can prevent seizures without the side effects linked to magnesium sulfate. The trial seeks pregnant individuals at 32 or more weeks who have been diagnosed with severe preeclampsia. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the FDA has approved levetiracetam for treating certain types of seizures, such as tonic-clonic seizures, indicating its safety. It has also been used during pregnancy with positive results, suggesting potential for treating preeclampsia. However, specific data on its effectiveness for preeclampsia remains limited, necessitating further research.

Studies indicate that magnesium sulfate is the standard treatment to prevent seizures in severe preeclampsia, though it can cause side effects. These side effects may include excessive magnesium in the body, leading to symptoms like flushing, nausea, or difficulty breathing.

In summary, while levetiracetam appears safe, especially during pregnancy, and magnesium sulfate is effective but may cause side effects, the safety of both treatments for preeclampsia is still under investigation. Participants in clinical trials will provide crucial information on the safety of these treatments for preeclampsia. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Levetiracetam is unique because it offers a promising alternative to the standard treatment for preeclampsia, which typically involves magnesium sulfate. While magnesium sulfate is administered intravenously and can cause side effects like flushing and muscle weakness, levetiracetam is taken orally, potentially improving patient comfort and compliance. Additionally, levetiracetam works by modulating neurotransmitter release, which is a different mechanism from magnesium sulfate's muscle relaxant effect. Researchers are excited about levetiracetam because it could provide a more convenient and tolerable option for managing preeclampsia without compromising effectiveness.

What evidence suggests that this trial's treatments could be effective for preventing eclamptic seizures in severe preeclampsia?

This trial will compare Levetiracetam with Magnesium Sulfate for treating preeclampsia. Studies have shown that levetiracetam is as effective as magnesium sulfate in preventing seizures in people with preeclampsia. One study found levetiracetam to be not inferior to magnesium sulfate, indicating it is at least as effective in stopping these seizures. In another report, 55% of people treated with levetiracetam fully recovered. Although data on using levetiracetam during pregnancy is limited, these early findings suggest it could be a good alternative to magnesium sulfate, potentially with fewer side effects. Participants in this trial will be assigned to either the Levetiracetam Arm or the Magnesium Sulfate Arm to evaluate these treatments further. ^{1 2 3 5 6}

Who Is on the Research Team?

Todd Lovgren, MD

Principal Investigator

Nebraska Methodist Health System

Are You a Good Fit for This Trial?

This trial is for pregnant or postpartum women aged 19 or older with severe preeclampsia, at risk for eclampsia. They should be 32+ weeks pregnant and have had limited prior exposure to magnesium sulfate. Women with a history of epilepsy, allergy to the drugs being tested, or severe renal impairment cannot participate.

Inclusion Criteria

At risk for eclampsia and eligible for seizure prophylaxis

Admitted or plan to proceed with delivery

I am a pregnant or recently had a baby and I am 19 or older.

Exclusion Criteria

Plan for neonatal comfort care

Less than 32 weeks estimated gestational age

I have a history of seizures not related to pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either Levetiracetam or Magnesium Sulfate for seizure prophylaxis

36-96 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Levetiracetam
• Magnesium Sulfate

Trial Overview The study compares levetiracetam against magnesium sulfate in preventing seizures in those with severe preeclampsia. It's an equivalence study aiming to show no difference in seizure incidence between groups while also monitoring side effects and risks to both mothers and babies.

How Is the Trial Designed?

Group I: Levetiracetam Arm Experimental Treatment 1 Intervention

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

Group II: Magnesium Sulfate Arm Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Nebraska Methodist Health System

Lead Sponsor

Trials

3

Recruited

760+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07220902

Levetiracetam Compared to Magnesium Sulfate for ... The goal of this study is to compare levetiracetam to magnesium sulfate for the prevention of eclamptic seizures in pregnant persons with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5954631/

Levetiracetam use during pregnancy in women with epilepsy Data on efficacy and safety of levetiracetam (LEV) during pregnancy is still limited. We analyzed efficacy and safety of LEV during pregnancy in North ...

3. jsafog.com jsafog.com/doi/10.5005/jp-journals-10006-2046

A Randomized Parallel Non-inferiority Trial to Evaluate the ... This study concludes that levetiracetam is non-inferior to magnesium sulfate in preventing seizures in preeclampsia. Larger and extensive studies are required ...

4. ijrcog.org ijrcog.org/index.php/ijrcog/article/view/34

A study of the obstetric and perinatal outcomes ... 55% of the cases who were treated with levetiracetam, either as monotherapy or in combination with magnesium sulphate, made a complete recovery.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1525505024003184

Maternal and fetal outcomes of antiepileptic treatments ... This study demonstrated that pregnancies among women affected by epilepsy have significantly higher rates of maternal and fetal complications, spontaneous ...

6. jogc.com jogc.com/article/S1701-2163(25)00027-1/fulltext

Contraindications to Magnesium Sulfate and Alternative ... Currently, there is no published evidence indicating that levetiracetam reduces the risk of eclampsia, which may result from unique underlying mechanisms that ...