SP0968 A Multicenter, Open-Label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures Brief summary 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. Medical Condition Electroencephalographic neonatal seizures Min. Age - Max. Age 28 Days Who Can Join? All Status Recruiting Inclusion criteria -Participant must be ≥34 weeks of corrected gestational age (CGA), <46 weeks of CGA, and <28 days of postnatal age (PNA) -Participants who have confirmation on video-electroencephalogram (EEG) of ≥2 minutes of cumulative electroencephalographic neonatal seizures (ENS) or ≥3 identifiable ENS prior to entering the Treatment Period -Participants must have received either phenobarbital (PB), levetiracetam (LEV), or midazolam (MDZ) (in any combination) before entering the study -Participant weighs at least 2.3 kg at the time of enrollment Informed consent -An Independent Ethics Committee (IEC)-approved written informed consent form (ICF) is signed and dated by the participant’s parent(s) or legal representative(s) Exclusion criteria -Participant with seizures responding to correction of metabolic disturbances (hypoglycemia, hypomagnesemia, or hypocalcemia) or with seizures for which a targeted, known treatment is available -Participant has seizures related to prenatal maternal drug use or drug withdrawal -Participant has a clinically relevant electrocardiogram (ECG) abnormality, in the opinion of the investigator -Participant receiving treatment with phenytoin (PHT), lidocaine (LDC), or other sodium channel blockers at any time Study Medication Description Study Medication: Vimpat? Other Descriptive Name: lacosamide Placebo No Comparator: Yes Share this study Refer to a friend Via email Study Dates March 2021 Actual Start Date of Enrollment August 2024 Planned Study Completion Date General Information Study ID: SP0968 EudraCT Number: CT.gov Number: Phase: Phase 2 Locations Interested in our clinical studies? Just contact us Austria 金禾娱乐城Cares.AT@ucb.com +43 (0) 1 291 80 08 0800-296176 (freephone) Belgium 金禾娱乐城Cares.BE@ucb.com +32 2 559 92 00 0800 38 008 (freephone) Bulgaria 金禾娱乐城Cares.BG@ucb.com +359 2 962 9933 Canada +1 866 709 8444 Czech Republic 金禾娱乐城Cares.CZ@ucb.com +420 221 773 442 800 144 395 (freephone) Denmark 金禾娱乐城Cares.DK@ucb.com +45 32462480 80 253827 (freephone) Finland 金禾娱乐城Cares.FI@ucb.com +358 942733300 0800 9 13353 (freephone) France 金禾娱乐城Cares.FR@ucb.com +33 1 47 29 45 55 0 805 222 949 (freephone) Germany 金禾娱乐城Cares.DE@ucb.com +49 2173 48 48 48 Greece 金禾娱乐城Cares.GR@ucb.com +30 21 0997 4200 0080 012 9910 (freephone) Hungary 金禾娱乐城Cares.HU@ucb.com +36 1 472 5060 06 80 021 486 (freephone) Ireland 金禾娱乐城Cares.IE@ucb.com +353 1 463 2371 1800 93 00 75 (freephone) Italy 金禾娱乐城Cares.IT@ucb.com +39 02 3007 9300 8009-86932 (freephone) Japan Luxemburg 金禾娱乐城Cares.LU@ucb.com +32 2 559 92 12 8002 3204 (freephone) Norway 金禾娱乐城Cares.NO@ucb.com +45 32462482 800-10101 (freephone) Poland 金禾娱乐城Cares.PL@ucb.com +48 22 596 97 97 00 800 121 68 25 (freephone) Portugal 金禾娱乐城Cares.PT@ucb.com +351 213 025 300 800-8-56033 (freephone) Romania +4021 300 19 07 Slovakia 金禾娱乐城Cares.SK@ucb.com +421 2 592 020 23 0800 002 566 (freephone) Spain 金禾娱乐城Cares.ES@ucb.com +34 915 70 06 49 8000-99684 (freephone) Sweden 金禾娱乐城Cares.SE@ucb.com +45 32462481 0200 898 671 (freephone) Switzerland +41 58 822 3180 The Netherlands 金禾娱乐城Cares.NL@ucb.com +31 76 573 1130 0800 3434335 (freephone) UK 金禾娱乐城Cares.UK@ucb.com +44 1753 777 100 0800 279 3177 (freephone) USA 金禾娱乐城Cares@ucb.com +1-844-599-2273 Email Print Back to results
