A Phase 2A Trial of EPI-743 for Patients With Parkinson's... | NCT01923584

Studies
A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease

NCT01923584

Sponsor

University of South Florida

Status

Completed

Last Update Posted

Sep 19, 2016Estimated

Enrollment

15Actual

Phase

Phase 2

Conditions

Parkinson's Disease

Interventions

EPI-743 400mg
EPI-743 200mg

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Jun 2016Actual

First Submitted Date

Aug 13, 2013

First Submission Date that Met QC Criteria

Aug 13, 2013

First Posted Date

Aug 15, 2013Estimated

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

Sep 16, 2016

Last Update Posted Date

Sep 19, 2016Estimated

Name	Class
Edison Pharmaceuticals Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EPI-743 400mg	Active Comparator	EPI-743 at a dose of 400 mg three times daily	Drug: EPI-743 400mg
EPI-743 200mg	Active Comparator	EPI-743 at a dose of 200 mg three times daily	Drug: EPI-743 200mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EPI-743 400mg	Drug		EPI-743 400mg
EPI-743 200mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual function	electroretinogram and color vision	3 months

Secondary Outcomes

Measure	Description	Time Frame
Neurologic function	UPDRS subscales	3 months
Motor function	UPDRS subscales	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Parkinson's disease
Age 40 - 75
Ambulatory with or without assistance
Hoehn and Yahr Scale score of 1 - 3
Patient able to consent and comply with protocol requirements
Abstention from use of Coenzyme Q10, vitamin E, Azilect and Idebenone two weeks prior to enrollment and during course of treatment with EPI-743

Exclusion Criteria:

Allergy to EPI-743 or sesame oil
Allergy to vitamin E
Clinical history of bleeding or abnormal baseline PT/PTT
Diagnosis of any other neurologic disease
Malignancy within past two years
Pregnant or plans to become pregnant
Concomitant ophthalmologic disease
History of stroke
History of brain surgery
Inability to undergo MRI scan or MRS
Hepatic insufficiency with LFTs greater than two times upper limit of normal
Renal insufficiency requiring dialysis
End stage cardiac failure
Fat malabsorption syndromes precluding drug absorption
Use of anticoagulant medications, azilect

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Theresa Zesiewicz, MD	University of South Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of South Florida		Tampa	Florida	33612	United States

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C571746	alpha-tocotrienol quinone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided