Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON]
1 other identifier
expanded_access
N/A
1 country
1
Brief Summary
Expanded access Protocol to treat LHON subjects with EPI743
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2014
CompletedFirst Posted
Study publicly available on registry
November 25, 2014
CompletedNovember 25, 2014
November 1, 2014
November 21, 2014
November 24, 2014
Conditions
Interventions
EPI-743 is a quinone oxidation product of alpha-tocotrienol
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Doheny Eye Institute / UCLA
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2014
First Posted
November 25, 2014
Last Updated
November 25, 2014
Record last verified: 2014-11