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Clinical trials for Infantile Spasms

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   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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    16 result(s) found for: Infantile Spasms. Displaying page 1 of 1.
    EudraCT Number: 2017-000230-62 Sponsor Protocol Number: EFC12369 Start Date*: 2017-04-24
    Sponsor Name:Alfresa Pharma Corporation and Sanofi KK
    Full Title: A Phase III study of M071754 - A single-blind study in patients with infantile spasms.
    Medical condition: Patients diagnosed with infantile spasms
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029205 - Nervous system disorders 10021750 Infantile spasms PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000611-17 Sponsor Protocol Number: LTS12745 Start Date*: 2017-08-28
    Sponsor Name:Alfresa Pharma Corporation and Sanofi KK
    Full Title: A Long term study of M071754 - A open-label study in patients with infantile spasms.
    Medical condition: Patients diagnosed with infantile spasms
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10021750 Infantile spasms PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-002107-26 Sponsor Protocol Number: EP0078 Start Date*: 2016-10-24
    Sponsor Name:UCB Biopharma SPRL
    Full Title: AN OPEN-LABEL ADAPTIVE STUDY FOR THE ASSESSMENT OF SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MULTIPLE DOSES OF RADIPRODIL IN SUBJECTS WITH DRUG-RESISTANT INFANTILE SPASMS
    Medical condition: Infantile spasms (IS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10021750 Infantile spasms PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) BE (Prematurely Ended) DE (Prematurely Ended) BG (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-003015-26 Sponsor Protocol Number: AMZ002-002 Start Date*: 2022-04-12
    Sponsor Name:Amzell B.V.
    Full Title: A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms
    Medical condition: Monotherapy for the treatment of infantile spasms (IS) in infants and children 2 months to 24 months of age
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10021750 Infantile spasms PT
    21.1 10029205 - Nervous system disorders 10021751 Infantile spasms, with intractable epilepsy LLT
    20.0 10029205 - Nervous system disorders 10021752 Infantile spasms, without mention of intractable epilepsy LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) FR (Ongoing) PL (Prematurely Ended) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-004286-33 Sponsor Protocol Number: 1042-0501 Start Date*: 2007-05-11
    Sponsor Name:Marinus Pharmceuticals, Inc.
    Full Title: An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in treatment of patients diagnosed with infantile spasms.
    Medical condition: Infantile spasms
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021750 Infantile spasms LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Ongoing)
    Trial results: View results
    EudraCT Number: 2006-004285-13 Sponsor Protocol Number: 1042-0500 Start Date*: 2007-05-11
    Sponsor Name:Marinus Pharmaceuticals, Inc.
    Full Title: A double-blind, placebo-controlled, dose-ranging clinical study to evaluate the safety, tolerability, and antiepileptic activity of ganaxolone in treatment of patients with infantile spasms.
    Medical condition: Infantile spasms
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021750 Infantile spasms LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-004904-50 Sponsor Protocol Number: GWEP15100 Start Date*: Information not available in EudraCT
    Sponsor Name:GW Research Ltd
    Full Title: A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Cannabidiol (GWP42003-P) in infants with Infantile Spasms following an initial open label pilot study.
    Medical condition: Infantile Spasms
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10021750 Infantile spasms PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-000360-17 Sponsor Protocol Number: TGO-VGB-III-01 Start Date*: Information not available in EudraCT
    Sponsor Name:TARGEON
    Full Title: Acceptability study of a new paediatric form of vigabatrin in infants and children with infantile spasms or pharmaco-resistant partial epilepsy. Observational, descriptive, open-label, multi-centr...
    Medical condition: Infantile spasms and pharmaco-resistant partial epilepsy
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029205 - Nervous system disorders 10021750 Infantile spasms PT
    18.0 10029205 - Nervous system disorders 10065336 Partial epilepsy LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-000788-27 Sponsor Protocol Number: RD01273 Start Date*: 2006-04-20
    Sponsor Name:Royal United Hospital Bath NHS Trust
    Full Title: International Collaborative Infantile Spasms Study (ICISS)
    Medical condition: Infantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually under the age of 1 year. Affected infants have a very abnormal EEG and a poor prognosis for subseque...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004775-30 Sponsor Protocol Number: Na Start Date*: 2018-05-09
    Sponsor Name:Kirsi Mikkonen/Helsinki University Hospital
    Full Title: PREDICTION AND PREVENTION OF INFANTILE SPASMS IN HIGH RISK CHILDREN
    Medical condition:
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-002710-23 Sponsor Protocol Number: P140203 Start Date*: Information not available in EudraCT
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10054935 Aicardi's syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2025-000001-16 Sponsor Protocol Number: I4V-JE-JAJE Start Date*: 2025-02-19
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 2/3, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Baricitinib in Adult and Pediatric Japanese Patients with NNS/CANDLE, SAVI, and AGS
    Medical condition: Nakajo-Nishimura Syndrome, Chronic Atypical Neutrophilic Dermatosis with Lipodystrophy and Elevated Temperature Syndrome, STING-Associated Vasculopathy with Onset in Infancy, Aicardi Goutieres Sy...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10073960 CANDLE syndrome PT
    21.1 10047065 - Vascular disorders 10047115 Vasculitis PT
    27.1 10010331 - Congenital, familial and genetic disorders 10054935 Aicardi's syndrome PT
    Population Age: Children, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2021-003441-38 Sponsor Protocol Number: 1042-TSC-3001 Start Date*: Information not available in EudraCT
    Sponsor Name:Marinus Pharmaceuticals Inc.
    Full Title: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC)
    Medical condition: Tuberous Sclerosis Complex (TSC)-related epilepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032062 Other forms of epilepsy, with intractable epilepsy LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) ES (Completed) IT (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005571-39 Sponsor Protocol Number: 4859 Start Date*: 2022-04-21
    Sponsor Name:Inselspital, Bern University Hospital
    Full Title: High Dose Steroids in Children with Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial
    Medical condition: Focal cerebral arteriopathy and childhood stroke Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection.
    Disease: Version SOC Term Classification Code Term Level
    22.1 100000004852 10055221 Ischemic stroke LLT
    20.0 100000004866 10003209 Arteriopathy LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002132-67 Sponsor Protocol Number: GWEP17005 Start Date*: 2021-10-22
    Sponsor Name:GW Research Ltd
    Full Title: An Open-Label, Randomized Trial to Assess the Safety, Pharmacokinetics, and Exploratory Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) Compared with Standard of Care Antiseizure Medi...
    Medical condition: Tuberous Sclerosis Complex (TSC)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10045138 Tuberous sclerosis LLT
    21.0 10010331 - Congenital, familial and genetic disorders 10080584 Tuberous sclerosis complex PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2013-002195-40 Sponsor Protocol Number: 13/0656 Start Date*: 2014-09-02
    Sponsor Name:University College London
    Full Title: A randomised controlled trial of the ketogenic diet in the treatment of epilepsy in children under the age of two years
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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