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NEOLEV3: A Phase IIb Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures of Mild to Moderate Severity IND-109622 (September 6, 2020)

Award Number: R01FD006335
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2022
PERIOD OF PERFORMANCE END DATE: 07/31/2027

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NEOLEV3: A Phase IIb Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures of Mild to Moderate Severity IND-109622 (September 6, 2020) - Project Summary/Abstract The aim of this proposal is to improve the treatment of neonatal seizures. Neonatal seizures affect 1 in 300 infants. Survivors have high rates (40-60%) of permanent disabilities such as cerebral palsy, global developmental delay and epilepsy. There is mounting evidence that seizures contribute to brain injury and neurodevelopmental disability; better treatment may improve long-term neurodevelopmental outcomes. Despite the randomized NEOLEV2 clinical trial showing greater seizure control with phenobarbital (PHB), PHB produced increased acute side effects in comparison to standard dose Levetiracetam (LEV). These side effects included respiratory suppression, hypotension, and sedation. Furthermore, there has been concern regarding long-term neurocognitive side effects of PHB. This proposed project will refine the standard clinical paradigm for neonatal seizure treatment by demonstrating a stratified approach; using an anti-seizure treatment with a significantly improved effect profile, LEV, targeted at reducing mild to moderate seizure burden, reserving PHB with its associated side effects for neonates with high seizure burden. Research Objectives are to (1) optimize the use of a newer, safer, non-toxic anticonvulsant medication for neonates with seizures and (2) develop technologies that will allow for accurate immediate automated diagnosis of seizures. A dose escalation and safety study will be performed to determine the maximum tolerated dose of LEV. Infants who continue to have seizures following standard dose LEV will receive either higher dose LEV or the control drug PHB, randomized in a 3:1 allocation ratio. Dose escalation will proceed in 3 phases to the maximal loading dose of 150mg/kg. A minimum of 10 subjects will be studied at each dosing level and safety data will determine if dose limiting toxicity has been demonstrated before further dose escalation. The primary endpoint will be the maximum tolerated dose. A secondary endpoint will be the additional efficacy of higher doses of LEV compared with standard dose LEV. The pharmacokinetics of high dose LEV in neonates will be studied. Facilitating early detection and rapid treatment of neonatal seizures is of equal importance to developing better drugs in improving outcomes. The usefulness of current seizure detection algorithms is limited by their low accuracy. Within the proposed study the accuracy of the new and improved Persyst neonatal seizure detection algorithm will be evaluated.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $703,432 )
2025	2025	REGENTS OF THE UNIVERSITY OF MINNESOTA	2221 UNIVERSITY AVE SE STE 100	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Food and Drug Administration Research	002	3	7/21/2025	NON-COMPETING CONTINUATION	$703,432
2025	2024	REGENTS OF THE UNIVERSITY OF MINNESOTA	2221 UNIVERSITY AVE SE STE 100	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Food and Drug Administration Research	001	2	5/23/2025	NON-COMPETING CONTINUATION	$0
2025	2022	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Food and Drug Administration Research	000	1	12/10/2024	NEW	$0
														Subtotal = $703,432

Issue Date FY: 2024 ( Subtotal = $703,302 )
2024	2024	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Food and Drug Administration Research	001	2	8/13/2024	NON-COMPETING CONTINUATION	$0
2024	2024	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Food and Drug Administration Research	000	2	8/2/2024	NON-COMPETING CONTINUATION	$703,302
														Subtotal = $703,302

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Food and Drug Administration Research	000	1	11/2/2022	NEW	$0
2023	2022	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Food and Drug Administration Research	002	1	8/29/2023	NEW	$0
2023	2022	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Food and Drug Administration Research	001	1	8/15/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $580,471 )
2022	2022	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Food and Drug Administration Research	000	1	9/22/2022	NEW	$580,471
														Subtotal = $580,471

Grand Total All Awards = $1,987,205

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NEOLEV3: A Phase IIb Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures of Mild to Moderate Severity IND-109622 (September 6, 2020)

Award Number: R01FD006335

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/20/2022

PERIOD OF PERFORMANCE END DATE: 07/31/2027

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