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NCT02300753 Clinical Trial

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

Leber's Hereditary Optic Neuropathy Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT02300753
Other study ID # EPI-2010-004
Secondary ID
Status No longer available
Phase N/A
First received November 21, 2014
Last updated November 24, 2014

Study information
Verified date November 2014
Source Edison Pharmaceuticals Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial Summary

Expanded access Protocol to treat LHON subjects with EPI743

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 8 Years to 65 Years
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• EPI-743
EPI-743 is a quinone oxidation product of alpha-tocotrienol

Locations
Country Name City State
United States Doheny Eye Institute / UCLA Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Edison Pharmaceuticals Inc

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT01421381 - RHODOS Follow-up Single-visit Study N/A
Completed NCT00747487 - Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy Phase 2
Completed NCT04909398 - Pupil Dynamics and Color Vision for the Detection of Eye Diseases N/A
Completed NCT02693119 - A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy Phase 2
Active, not recruiting NCT02161380 - Safety Study of an Adeno-associated Virus Vector for Gene Therapy of Leber's Hereditary Optic Neuropathy Phase 1
Withdrawn NCT01495715 - Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON) Phase 3
No longer available NCT04381091 - Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study