Emergency Administration of EPI-743 to a Single Patient W... | NCT02300753

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

NCT02300753

Sponsor

Edison Pharmaceuticals Inc

Status

No longer available

Last Update Posted

Nov 25, 2014Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Leber's Hereditary Optic Neuropathy

Interventions

EPI-743

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

No longer available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 21, 2014

First Submission Date that Met QC Criteria

Nov 24, 2014

First Posted Date

Nov 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2014

Last Update Posted Date

Nov 25, 2014Estimated

Description Module

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.

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
EPI-743	Drug	EPI-743 is a quinone oxidation product of alpha-tocotrienol		Vincerinone (TM) Vatiquinone

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Doheny Eye Institute / UCLA		Los Angeles	California	90033	United States

Condition Browse Module

MeSH Terms

ID	Term
D029242	Optic Atrophy, Hereditary, Leber

Ancestor Terms

ID	Term
D015418	Optic Atrophies, Hereditary
D009896	Optic Atrophy
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases

Browse Leaves

Not provided

Browse Branches

Not provided