Levetiracetam vs Magnesium Sulfate for Preeclampsia
(LEVMag Trial)
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.12345Why 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.12356
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Levetiracetam or Magnesium Sulfate for seizure prophylaxis
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
This experimental arm will receive oral levetiracetam 3 times daily after an initial loading oral dose.
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nebraska Methodist Health System
Lead Sponsor
Citations
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 ...
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 ...
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 ...
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.
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 ...
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 ...
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