Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON]

NO_LONGER_AVAILABLE

Conditions studied: Leber's Hereditary Optic Neuropathy

In brief

Expanded access Protocol to treat LHON subjects with EPI743

Key facts

Study ID

NCT02300753

Run by

Edison Pharmaceuticals Inc

Last updated by the study team

2014-11-25

Who can join

Age: 8 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Doheny Eye Institute / UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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