A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
Terminated · Phase 2 · NCT04519645
Conditions: Electroencephalographic Neonatal Seizures, Epilepsy
At a glance
- Research payments reported, 2025
- $320,013
- U.S. investigators named
- 13
- Sites paid
- 13
- Planned or actual enrollment
- 29
About the trial
- Sponsor
- UCB Biopharma SRL
- Tested
- Lacosamide intravenous (drug), Lacosamide oral (drug), Active Comparator (other)
- Dates
- Started 2021-03-31; completion 2024-10-31
- Results posted
- Yes
The purpose of the study is to evaluate the efficacy of lacosamide (LCM) versus an Active Comparator chosen based on standard of care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.
From ClinicalTrials.gov, last updated 2025-10-03. Full record, eligibility and contacts (opens in a new tab)
Industry funding
UCB SA reported $320,013 in research payments for this study in 2025 (14 payments).
Products named: Vimpat
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Nicole H. Cobo, M.D. Child Neurology · Long Beach, CA
- Jeffrey J. Gold, MD, PH.D. Child Neurology · San Diego, CA
- Lekha M. Rao, M.D. Pediatrics · Los Angeles, CA
- Krista L. Eschbach, MD Neurology · Aurora, CO
- Teresa Delmoral, MD Neonatology · Miami, FL
- Anuj Jayakar, MD Child Neurology · Miami, FL
- Theresa M. Czech, MD Neurology · Iowa City, IA
- Steven Wolf, MD Neurology · New York, NY
- Dave F. Clarke, MD Child Neurology · Austin, TX
- Simon Kayyal, MD Pediatrics · Houston, TX
- Mariana C. Baserga, M.D. Neonatology · Salt Lake City, UT
- Kristen C. Heinan, M.D. Child Neurology · Roanoke, VA
- Niranjana Natarajan, M.D. Child Neurology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- University of Utah Hospital and Clinics, UT $113,706
- Children's Hospital Colorado, CO $39,227
- University of California San Diego Jacobs Medical Center $31,039
- Nicklaus Children's Hospital, FL $29,582
- University of Virginia Medical Center, VA $23,605
- Ascension Seton Medical Center Austin, TX $13,900
- University of Iowa Hospital & Clinics, IA $13,858
- Children's Hospital of Orange County, CA $12,934
- University of Kentucky Research Foundation $10,290
- Ronald Reagan UCLA Medical Center, CA $9,009
- Memorial Health Services $8,899
- Seattle Children's Hospital, WA $8,071
- Altoona Center for Clinical Research $5,893
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.