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

Status:

NO_LONGER_AVAILABLE

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

Lead Sponsor:

Edison Pharmaceuticals Inc

Conditions:

Leber's Hereditary Optic Neuropathy

Eligibility:

All Genders

8-65 years

Brief Summary

Expanded access Protocol to treat LHON subjects with EPI743

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.

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT02300753

Last Update

November 25 2014

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