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Clinical trials for Vigabatrin

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    19 result(s) found for: Vigabatrin. Displaying page 1 of 1.
    EudraCT Number: 2020-003231-19 Sponsor Protocol Number: ViRap Start Date*: Information not available in EudraCT
    Sponsor Name:The Children's Memorial Health Institute
    Full Title: Randomized, placebo-controlled, double-blind and double-dummy clinical trial comparing the safety, tolerability, and efficacy of vigabatrin and rapamycin in a preventive treatment of infants with T...
    Medical condition: Tuberous Sclerosis Complex Epilepsy Tumors associated with Tuberous Sclerosis Complex
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    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: 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: 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: 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: 2013-005528-40 Sponsor Protocol Number: EPISTOP Start Date*: 2014-12-05
    Sponsor Name:The Children's Memorial Health Institute
    Full Title: Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – Tuberous Sclerosis Complex.
    Medical condition: Epilepsy in tuberous sclerosis complex (TSC)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004852 10032061 Other forms of epilepsy LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed)
    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: 2017-000230-62 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: 2007-003834-40 Sponsor Protocol Number: 07NR07 Start Date*: 2008-10-31
    Sponsor Name:UCL-INSTITUTE OF CHILD HEALTH
    Full Title: THE IMPACT OF REDUCING OVERTREATMENT ON QUALITY OF LIFE IN CHILDREN WITH REFRACTORY EPILEPSY
    Medical condition: We are studying a population of children with refractory epilepsy.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10053551 Intractable epilepsy LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-000531-27 Sponsor Protocol Number: NL43510 Start Date*: 2014-02-11
    Sponsor Name:University Medical Center Utrecht
    Full Title: Corticosteroids or clobazam for ESES syndrome: a European, multicenter, randomized, controlled clinical trial
    Medical condition: Encephalopathy with electrical status epilepticus in sleep, also called ESES syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032061 Other forms of epilepsy LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) FI (Completed) ES (Prematurely Ended) BE (Completed) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) FR (Ongoing) DK (Completed) IT (Ongoing)
    Trial results: View results
    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
    EudraCT Number: 2012-000062-38 Sponsor Protocol Number: 191622-101 Start Date*: 2013-07-08
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment in Pediatric Upper Limb Spasticity: Double-blind Study
    Medical condition: Upper Limb Spasticity.
    Disease: Version SOC Term Classification Code Term Level
    15.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    15.1 10029205 - Nervous system disorders 10048970 Arm spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000042-35 Sponsor Protocol Number: 191622-111 Start Date*: 2013-07-08
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study
    Medical condition: Lower Limb Spasticity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    14.1 10029205 - Nervous system disorders 10024132 Leg spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000043-27 Sponsor Protocol Number: 191622-105 Start Date*: Information not available in EudraCT
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment in Pediatric Upper Limb Spasticity: Open-label Study
    Medical condition: Upper limb spasticity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    14.1 10029205 - Nervous system disorders 10048970 Arm spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000084-24 Sponsor Protocol Number: 191622-112 Start Date*: 2013-07-08
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment of Pediatric Lower Limb Spasticity: Open-label Study
    Medical condition: Lower Limb Spasticity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    14.1 10029205 - Nervous system disorders 10024132 Leg spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (Completed)
    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: 2011-004980-63 Sponsor Protocol Number: 191622-116 Start Date*: 2012-02-08
    Sponsor Name:Allergan Ltd.
    Full Title: BOTOX® Treatment in Adult Patients with Post-Stroke Lower Limb Spasticity
    Medical condition: Post-Stroke Lower Limb Spasticity
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004852 10042244 Stroke LLT
    16.1 100000004852 10024132 Leg spasticity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) GB (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2004-000483-27 Sponsor Protocol Number: PRA/BIA-2093-302 Start Date*: 2004-08-19
    Sponsor Name:BIAL - Portela & Ca, S.A.
    Full Title: Efficacy and safety of BIA 2-093 as adjunctive therapy for refractory partial seizures in a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial.
    Medical condition: Refractory partial epilepsy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2008-002455-25 Sponsor Protocol Number: BIA-2093-304 Start Date*: 2008-09-18
    Sponsor Name:BIAL - Portela & Cª, SA
    Full Title: EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS ADJUNCTIVE THERAPY FOR REFRACTORY PARTIAL SEIZURES IN A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINI...
    Medical condition: simple partial seizures with no motor symptomatology Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10065336 Partial epilepsy LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) IT (Completed) DE (Completed) GR (Completed) CY (Completed) HU (Completed) RO (Ongoing)
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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