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Trial record 1 of 3 for:    "Leber Optic Atrophy" | "Micronutrients"
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Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON]

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ClinicalTrials.gov Identifier: NCT02300753
Expanded Access Status : No longer available
First Posted : November 25, 2014
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Edison Pharmaceuticals Inc

Brief Summary:
Expanded access Protocol to treat LHON subjects with EPI743

Condition or disease Intervention/treatment
Leber's Hereditary Optic Neuropathy Drug: EPI-743

Detailed Description:
Emergency use administration of EPI-743 to subjects with LHON. This Protocol was originally developed to treat a single subject but was expanded to treat several at a single institution.

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Study Type : Expanded Access
Official Title: Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON]



Intervention Details:
  • Drug: EPI-743
    EPI-743 is a quinone oxidation product of alpha-tocotrienol
    Other Names:
    • Vincerinone (TM)
    • Vatiquinone

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Emergency treatment for subjects with LHON who are actively losing site in one eye

Exclusion Criteria:

  • Allergy to EPI-743 or sesame oil
  • Clinical history of bleeding or abnormal PT/PTT
  • Hepatic insufficiency with LFTs greater than 2-times normal
  • Renal insufficiency requiring dialysis
  • Fat malabsorption syndromes
  • Any other concurrent inborn erros of metabolism
  • Severe end-organ hypo-perfusion syndrome secondary to cardiac failure resulting in lactic acidosis
  • Anemia with a HCT <25

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300753


Locations
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United States, California
Doheny Eye Institute / UCLA
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Edison Pharmaceuticals Inc

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Responsible Party: Edison Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02300753     History of Changes
Other Study ID Numbers: EPI-2010-004
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Micronutrients
Optic Nerve Diseases
Optic Neuritis
Optic Atrophy, Hereditary, Leber
Emergencies
Disease Attributes
Pathologic Processes
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Optic Atrophies, Hereditary
Optic Atrophy
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases
Ubiquinone
Nutrients
Growth Substances
Physiological Effects of Drugs