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Clinical trials for Neonatal seizures

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    43 result(s) found for: Neonatal seizures. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2010-020797-41 Sponsor Protocol Number: NEMO1-08NR26 Start Date*: 2010-11-16
    Sponsor Name:Only for Children Pharmaceuticals
    Full Title: NEMO-1: An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent.
    Medical condition: Neonatal Seizures in Hypoxic Ischemic Encephalopathy
    Disease: Version SOC Term Classification Code Term Level
    15.0 10029205 - Nervous system disorders 10061197 Neonatal seizures LLT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) FI (Prematurely Ended) GB (Prematurely Ended) SE (Prematurely Ended) FR (Ongoing) NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-020103-70 Sponsor Protocol Number: 1 Start Date*: 2012-08-14
    Sponsor Name:University of Tartu
    Full Title: Pharmacokinetics of intravenous phenobarbital and lidocaine in the treatment of neonatal seizures of term neonates requireing therapeutic hypothermia
    Medical condition: Neonatal seizures
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: EE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-002756-27 Sponsor Protocol Number: N01349 Start Date*: Information not available in EudraCT
    Sponsor Name:UCB Biopharma SPRL
    Full Title: A multicenter, open-label, single-arm study to evaluate the pharmacokinetics, efficacy, and safety of brivaracetam in neonates with repeated electroencephalographic seizures
    Medical condition: Electroencephalographic neonatal seizures
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) BE (Prematurely Ended) CZ (Completed) HU (Completed) NL (Prematurely Ended) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-014260-19 Sponsor Protocol Number: CH/2009/3187 Start Date*: 2010-01-29
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: A feasibility study of adding xenon to cooling therapy in babies at high risk of brain injury following poor condition at birth
    Medical condition: Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.
    Disease: Version SOC Term Classification Code Term Level
    12 10028923 Neonatal asphyxia LLT
    12 10028923 Neonatal asphyxia PT
    12 10028946 Neonatal hypoxia and asphyxia HLT
    12 10050081 Neonatal hypoxia LLT
    12 10050081 Neonatal hypoxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-001066-10 Sponsor Protocol Number: SP0968 Start Date*: 2021-09-06
    Sponsor Name:UCB Biopharma SRL
    Full Title: A Multicenter, Open-Label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
    Medical condition: Electroencephalographic Neonatal Seizures (ENS)
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2009-016653-17 Sponsor Protocol Number: FARM73452X Start Date*: 2010-04-13
    Sponsor Name:AZIENDA UNITA` SANITARIA LOCALE N 12 DI VIAREGGIO
    Full Title: TREATMENT OF HYPOTENSION IN EXTREMELY PRETERM INFANTS: A MULTICENTER RANDOMIZED CONTROLLED TRIAL
    Medical condition: HYPOTENSION IN EXTREMELY PRETERM INFANTS
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049223 LLT
    9.1 10049223 LLT
    9.1 10049223 LLT
    9.1 10049223 LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-003771-35 Sponsor Protocol Number: UX007G-CL201 Start Date*: 2014-02-11
    Sponsor Name:Ultragenyx Pharmaceutical Inc
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adaptive Study to Assess the Safety and Efficacy of UX007 in Subjects with Glucose Transporter Type 1 Deficiency Syndrome
    Medical condition: Glucose Transporter Type 1 deficiency syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10039911 Seizures (incl subtypes) HLGT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) GB (Completed) FR (Ongoing) HU (Completed) ES (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-003063-12 Sponsor Protocol Number: NEU-01-02-1A Start Date*: 2016-09-14
    Sponsor Name:Neurophyxia B.V.
    Full Title: TIBC study: A multiple-centre Phase 2 trial comparing the efficacy of 2-Iminobiotin (2-IB) treatment to standard care in neonates with gestational age of ≥36 weeks with moderate to severe perinatal...
    Medical condition: Perinatal asphyxia
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003500 Asphyxia neonatal LLT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10004943 Birth asphyxia LLT
    19.0 100000004868 10028946 Neonatal hypoxia and asphyxia HLT
    19.0 100000004852 10021147 Hypoxic encephalopathy LLT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10022820 Intrauterine hypoxia and birth asphyxia LLT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10040441 Severe birth asphyxia LLT
    19.0 100000004852 10070512 Hypoxic-ischemic encephalopathy LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2013-004478-80 Sponsor Protocol Number: Issue1 Start Date*: 2014-01-08
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: XENON AND COOLING THERAPY IN BABIES AT HIGH RISK OF BRAIN INJURY FOLLOWING POOR CONDITION AT BIRTH: A RANDOMISED OUTCOME STUDY (COOLXENON3 STUDY)
    Medical condition: Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    16.1 100000004868 10028946 Neonatal hypoxia and asphyxia HLT
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10050081 Neonatal hypoxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2006-006804-12 Sponsor Protocol Number: ucb L059 Start Date*: 2007-03-15
    Sponsor Name:ErasmusMedical Center-Sophia
    Full Title: Levetiracetam (Keppra®) in neonates
    Medical condition: epileptic seizures in neonates admitted to the intensive care unit
    Disease: Version SOC Term Classification Code Term Level
    9.1 10041350 Somnolence neonatal LLT
    9.1 10013573 Dizziness LLT
    9.1 10004210 Behavioural disorder LLT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-002502-74 Sponsor Protocol Number: NEU-01-02-01 Start Date*: 2012-02-14
    Sponsor Name:Neurophyxia B.V.
    Full Title: A multi-centre, randomised, double-blind, placebo-controlled Phase II study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of 2-iminobiotin (2-IB) in neonates with gestational...
    Medical condition: Perinatal asphyxia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10004943 Birth asphyxia LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003500 Asphyxia neonatal LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-000043-74 Sponsor Protocol Number: PNAS0122 Start Date*: 2023-07-27
    Sponsor Name:Medical University of Vienna
    Full Title: Defining and predicting neonatal inadaptation after gestational exposure to antidepressants: longitudinal exploratory analysis of psychoneuroendocrine risk factors and complications
    Medical condition: major depressive disorder poor neonatal adaptation syndrome (after antidepressant use during pregnancy)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003410-12 Sponsor Protocol Number: RG_19-169 Start Date*: 2020-12-16
    Sponsor Name:University of Birmingham
    Full Title: Pregnancy ANtihypertensive Drugs: which Agent is best?
    Medical condition: Hypertension in pregnancy (chronic hypertension, gestational hypertension or pre-eclampsia)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2011-005397-34 Sponsor Protocol Number: Issue1 Start Date*: 2012-02-24
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: Xenon and cooling therapy in babies at high risk of brain injury following poor condition at birth: Randomised pilot study. (CoolXenon2 study)
    Medical condition: Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10050081 Neonatal hypoxia PT
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10028946 Neonatal hypoxia and asphyxia HLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-002154-12 Sponsor Protocol Number: GWEP1521 Start Date*: 2016-09-30
    Sponsor Name:GW Research Ltd.
    Full Title: A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experi...
    Medical condition: Tuberous Sclerosis Complex (TSC)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10045138 Tuberous sclerosis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Completed) GB (GB - no longer in EU/EEA) PL (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-005811-34 Sponsor Protocol Number: 24d005 Start Date*: 2018-07-05
    Sponsor Name:VU Medical Center, Amsterdam
    Full Title: Pregnancy reLated Acute hyperTension INtervention Action: a randomized trial comparing labetalol and nicardipine in women with acute hypertension in pregnancy (Platina-trial)
    Medical condition: To asses optimal treatment of hypertension of hypertensive disorders in pregnancy
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004496-12 Sponsor Protocol Number: 1042-PCDH19-3002 Start Date*: 2019-09-26
    Sponsor Name:Marinus Pharmaceuticals, Inc.
    Full Title: A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female children with protocadherin 19 (PCDH19)-related epilepsy followed by long-term open-label treatment
    Medical condition: protocadherin 19 (PCDH19)-related epilepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032061 Other forms of epilepsy LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Female
    Trial protocol: FR (Completed) NL (Prematurely Ended) PL (Completed) HU (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000860-90 Sponsor Protocol Number: CRAD001M2304 Start Date*: 2013-02-14
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC)...
    Medical condition: Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10045138 Tuberous sclerosis PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed) NL (Completed) DE (Completed) HU (Completed) GB (Completed) BE (Completed) GR (Completed) DK (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003341-15 Sponsor Protocol Number: FFIS/2019/01/AS Start Date*: 2022-10-21
    Sponsor Name:Fundación para la Formación e Investigación Sanitarias de la Región de Murcia (FFIS)
    Full Title: Aspirin versus placebo in twin pregnancies for preeclampsia prevention: A multicentre, randomised, double-blind, placebo-controlled trial.
    Medical condition: Pre-eclampsia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036485 Pre-eclampsia PT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing) AT (Ongoing) DK (Trial now transitioned) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-014344-11 Sponsor Protocol Number: prot-001-2009 Start Date*: 2010-06-02
    Sponsor Name:Imperial College London
    Full Title: Neuroprotective effects of hypothermia combined with inhaled xenon following perinatal asphyxia - the TOBY Xe trial
    Medical condition: Neonatal asphyxial encephalopathy
    Disease: Version SOC Term Classification Code Term Level
    12 10028946 neonatal hypoxia and asphyxia SOC
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
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