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

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Expanded access Protocol to treat LHON subjects with EPI743

Details

• Lead Sponsor: Edison Pharmaceuticals Inc
• Treatments: Ubiquinone

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