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Clinical trials for Fenfluramine

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   44344   clinical trials with a EudraCT protocol, of which   7373   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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    17 result(s) found for: Fenfluramine. Displaying page 1 of 1.
    EudraCT Number: 2020-002238-34 Sponsor Protocol Number: FFA-MAE-EXT Start Date*: 2021-03-22
    Sponsor Name:University Hospital Schleswig-Holstein (UKSH)
    Full Title: Open label extension study for monitoring long-term safety in patients with Myoclonic Astatic Epilepsy (Doose-Syndrome) receiving Fenfluramine as add-on therapy
    Medical condition: Childhood epilepsy: Myoclonic Astatic Epilepsy (Doose-Syndrome)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004850 10081183 Myoclonic-astatic epilepsy LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003222-76 Sponsor Protocol Number: ZX008-2103 Start Date*: 2022-08-19
    Sponsor Name:Zogenix International Limited
    Full Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, FIXED-DOSE, MULTICENTER STUDY TO EXAMINE THE EFFICACY AND SAFETY OF ZX008 IN SUBJECTS WITH CDKL5 DEFICIENCY DISORDER FOLLOWED BY AN OPEN-LABE...
    Medical condition: CDKL5 DEFICIENCY DISORDER
    Disease: Version SOC Term Classification Code Term Level
    22.1 10010331 - Congenital, familial and genetic disorders 10083005 CDKL5 deficiency disorder PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PT (Trial now transitioned) DE (Trial now transitioned) FR (Not Authorised) NL (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) IE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-004008-46 Sponsor Protocol Number: FFA-LGS Start Date*: 2016-01-07
    Sponsor Name:UZ Leuven
    Full Title: Add-on fenfluramine in Lennox Gastaut epilepsy
    Medical condition: Lennox Gastaut Epilepsy
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2017-002628-26 Sponsor Protocol Number: ZX008-1601 Start Date*: 2018-07-23
    Sponsor Name:Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.
    Full Title: A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochlo...
    Medical condition: Lennox-Gastaut Syndrome in Children and Adults
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) ES (Ongoing) AT (Prematurely Ended) DK (Completed) GB (GB - no longer in EU/EEA) IT (Completed) SE (Completed) NL (Completed) FR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-001331-31 Sponsor Protocol Number: ZX008-1900 Start Date*: 2019-11-07
    Sponsor Name:Zogenix International Limited
    Full Title: An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such a...
    Medical condition: Dravet syndrome or Lennox-Gastaut syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    20.0 100000004850 10073682 Dravet syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) DK (Completed) FR (Completed) ES (Ongoing) DE (Completed) SE (Completed) NL (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-004114-42 Sponsor Protocol Number: Start Date*: 2011-08-26
    Sponsor Name:University Hospital Antwerp
    Full Title: Fenfluramine as anti-epilepticum in Dravet syndrome.
    Medical condition: Fenfluramine is an amphetamine which was in the past used as anorexigan. Their are a few publications of effectivness of this medication in epilepsy.We want to investigate was is the exact place of...
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002804-14 Sponsor Protocol Number: ZX008-1503 Start Date*: 2016-11-08
    Sponsor Name:Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc
    Full Title: An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome
    Medical condition: Seizures associated with Dravet syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10073682 Dravet syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) DE (Completed) IT (Completed) DK (Completed) ES (Ongoing) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-000474-38 Sponsor Protocol Number: ZX008-1504 Start Date*: 2016-09-13
    Sponsor Name:Zogenix International Limited
    Full Title: A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), ...
    Medical condition: Dravet's syndrome
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10073682 Dravet syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-002821-32 Sponsor Protocol Number: FENDEEP Start Date*: 2021-12-09
    Sponsor Name:Neurologia Aplicada, SLP
    Full Title: The FENDEEP Study: Fenfluramine for the treatment of different types of developmental and epileptic encephalopathies: a pilot trial exploring epileptic and non-epileptic outcomes.
    Medical condition: Five different types of developmental and epileptic encephalopathies (DEEs): SYNGAP1 and STXBP1 encephalopathies, inv-dup(15) encephalopathy, multifocal or bilateral Malformations of Cortical Devel...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10053551 Intractable epilepsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-004167-37 Sponsor Protocol Number: ZX008-1502 Start Date*: 2016-05-17
    Sponsor Name:Zogenix International Limited
    Full Title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and You...
    Medical condition: Dravet's syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10073682 Dravet syndrome LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) BE (Completed) NO (Ongoing) DK (Completed) SE (Ongoing) ES (Completed) FR (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-001664-38 Sponsor Protocol Number: FFA-MAE Start Date*: 2019-10-02
    Sponsor Name:University Hospital Schleswig-Holstein (UKSH)
    Full Title: A proof of concept and assessment of maximal effect study with low dose Fenfluramine as add-on therapy in Myoclonic Astatic Epilepsy (Doose-Syndrome)
    Medical condition: Childhood epilepsy: Myoclonic Astatic Epilepsy (Doose-Syndrome)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004852 10015040 Epilepsy equivalent LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001187-33 Sponsor Protocol Number: APD811-301 Start Date*: 2019-02-12
    Sponsor Name:Arena Pharmaceuticals, Inc.
    Full Title: A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients
    Medical condition: pulmonary arterial hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077731 Pulmonary hypertension WHO functional class I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) SE (Prematurely Ended) GB (GB - no longer in EU/EEA) HU (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned) CZ (Trial now transitioned) BE (Trial now transitioned) BG (Trial now transitioned) NL (Trial now transitioned) GR (Trial now transitioned) PT (Trial now transitioned) IT (Trial now transitioned) HR (Completed) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-006192-13 Sponsor Protocol Number: C200-006 Start Date*: 2006-06-22
    Sponsor Name:Actelion Pharmaceuticals US, Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SI...
    Medical condition: Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10037400 Pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Prematurely Ended) AT (Prematurely Ended) ES (Completed) PT (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003309-88 Sponsor Protocol Number: ROR-PH-302 Start Date*: 2020-06-02
    Sponsor Name:United Therapeutics Corporation
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World He...
    Medical condition: pulmonary arterial hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077731 Pulmonary hypertension WHO functional class I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) AT (Prematurely Ended) DE (Prematurely Ended) ES (Ongoing) PL (Prematurely Ended) BE (Completed) IT (Prematurely Ended) PT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-000166-37 Sponsor Protocol Number: AIR001-CS05 Start Date*: 2013-01-22
    Sponsor Name:Aires Pharmaceuticals Inc
    Full Title: A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension
    Medical condition: Pulmonary Arterial Hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) CZ (Prematurely Ended) DE (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-002480-22 Sponsor Protocol Number: TAK-935-3001 Start Date*: 2021-07-22
    Sponsor Name:Takeda Development Center Americas, Inc
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Young Adul...
    Medical condition: Dravet Syndrome (DS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10073682 Dravet syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA IT (Completed) FR (Completed) ES (Completed) LV (Completed) GR (Completed) NL (Completed) BE (Completed) PL (Completed) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-002481-40 Sponsor Protocol Number: TAK-935-3002 Start Date*: 2021-07-22
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subj...
    Medical condition: Lennox-Gastaut Syndrome (LGS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA IT (Completed) FR (Completed) ES (Completed) LV (Completed) GR (Completed) NL (Completed) BE (Completed) PL (Completed) HU (Completed) DE (Completed)
    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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