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Clinical trials for LHON

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    9 result(s) found for: LHON. Displaying page 1 of 1.
    EudraCT Number: 2015-004405-16 Sponsor Protocol Number: SNT-IV-005 Start Date*: 2016-03-16
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Limited
    Full Title: External Natural History Controlled, open-Label Intervention Study to Assess the Efficacy and Safety of Long-Term Treatment with Raxone® in Leber’s Hereditary Optic Neuropathy (LHON)
    Medical condition: Leber’s Hereditary Optic Neuropathy / LHON is a maternally inherited loss of vision due to atrophy of the optic nerve. It typically presents in young adults, mostly men, as painless acute or subacu...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10062951 Leber's hereditary optic atrophy neuropathy LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) BE (Completed) PT (Completed) ES (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002187-40 Sponsor Protocol Number: GS-LHON-CLIN-05 Start Date*: 2018-03-15
    Sponsor Name:GENSIGHT BIOLOGICS
    Full Title: Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected with G11778A ND4 Leber Hereditary Optic Neuropathy for U...
    Medical condition: Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) NL (Ongoing) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-002679-42 Sponsor Protocol Number: SNT-II-003 Start Date*: 2006-11-22
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Limited
    Full Title: A double blind, randomised, placebo-controlled study of the efficacy, safety and tolerability of idebenone in the treatment of patients with Leber's Hereditary Optic Neuropathy
    Medical condition: Leber's Hereditary Optic Neuropathy
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-001034-42 Sponsor Protocol Number: SNT-II-003-OFU Start Date*: 2011-08-25
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Limited
    Full Title: A single visit, observational, follow-up study of Patients with Leber’s Hereditary Optic Neuropathy following participation in SNT-II-003 trial
    Medical condition: Leber’s Hereditary Optic Neuropathy
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10062951 Leber's hereditary optic atrophy neuropathy LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001405-90 Sponsor Protocol Number: GS-LHON/CLIN/01 Start Date*: 2013-12-26
    Sponsor Name:GENSIGHT-BIOLOGICS
    Full Title: A phase I/IIa, non randomized, escalating dose, open-label study to evaluate safety and efficacy of GS010 (rAAV2/2-ND4) in patients suffering from Leber Hereditary Optic Neuropathy due to mutations...
    Medical condition: Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10062951 Leber's hereditary optic atrophy neuropathy LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002153-11 Sponsor Protocol Number: GS-LHON-CLIN-06 Start Date*: 2018-02-12
    Sponsor Name:GENSIGHT BIOLOGICS
    Full Title: Long-term Follow-up of ND4 LHON Subjects Treated With GS010 Ocular Gene Therapy in the RESCUE or REVERSE Phase III Clinical Trials
    Medical condition: Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10062951 Leber's hereditary optic atrophy neuropathy LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-001265-11 Sponsor Protocol Number: GS-LHON-CLIN-03A Start Date*: 2016-01-21
    Sponsor Name:GENSIGHT-BIOLOGICS
    Full Title: A Randomized, Double-Masked, Sham-Controlled, Pivotal Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 (rAAV2/2-ND4) in Subjects Affected for 6 Months or Less by...
    Medical condition: Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001266-26 Sponsor Protocol Number: GS-LHON-CLIN-03B Start Date*: 2016-01-21
    Sponsor Name:GENSIGHT-BIOLOGICS
    Full Title: A Randomized, Double-Masked, Sham-Controlled, Pivotal Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 (rAAV2/2-ND4) in Subjects Affected for more than 6 months a...
    Medical condition: Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-016982-26 Sponsor Protocol Number: ST200-ODU-09-01 Start Date*: 2010-11-04
    Sponsor Name:SIGMA-TAU
    Full Title: Neuronal conduction along the visual patways after oral treatment with Acetyl-L-carnitine in patients with Leber’s Hereditary Optic Neuropathy
    Medical condition: Leber’s Hereditary Optic Neuropathy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061323 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
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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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