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Lacosamide for Neonatal Seizures (LENS Trial)
LENS Trial Summary
This trial will compare the efficacy of lacosamide to an active comparator chosen based on standard of care in reducing seizure burden in neonates with uncontrolled seizures.
LENS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLENS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LENS Trial Design
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Who is running the clinical trial?
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- You have seizures caused by your mother using drugs or going through drug withdrawal before you were born.My seizures improve with treatment for metabolic issues or have a known treatment.You have a heart problem that shows up on an electrocardiogram (ECG) test, according to the doctor.I weigh at least 2.3 kg.I have taken phenobarbital, levetiracetam, or midazolam before.I am currently taking medication like phenytoin or lidocaine.My baby is between 34 and 46 weeks old in corrected gestational age and less than 28 days old since birth.My EEG shows I've had significant neonatal seizures.
Frequently Asked Questions
Is this clinical trial taking place at more than one location within the United States?
"Currently, this trial is being conducted in Valhalla, New york; Rochester, Minnesota; and Orange, California--among 21 other locations."
How many people are included in this clinical research project?
"In order for this study to proceed, 32 patients who meet the necessary qualifications are required. The sponsor, UCB Biopharma SRL, will be administering the trial from multiple locations, such as Sp0968 107 in Valhalla, New york and Sp0968 125 in Rochester, Minnesota."
Are there any other ongoing or previous research studies that have included Lacosamide oral?
"As of right now, there are 4 ongoing studies that are researching the oral administration of Lacosamide. 3 of those studies are currently in Phase 3. Although the majority of the trials for Lacosamide oral are based in Jacksonville, Florida, there are a total of 166 locations running trials for this treatment."
Are new patients being accepted into this trial at this time?
"That is accurate. The listing on clinicaltrials.gov says that the research team is currently looking for 32 individuals to take part in the study at 21 different sites. The trial was first posted on March 31, 2021 and was last updated on October 6, 2022."
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