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

September 16, 2016 updated by: University of South Florida
The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • University of South Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of Parkinson's disease
  2. Age 40 - 75
  3. Ambulatory with or without assistance
  4. Hoehn and Yahr Scale score of 1 - 3
  5. Patient able to consent and comply with protocol requirements
  6. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EPI-743 400mg
EPI-743 at a dose of 400 mg three times daily
Drug: EPI-743 400mg
Active Comparator: EPI-743 200mg
EPI-743 at a dose of 200 mg three times daily
Drug: EPI-743 200mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurologic function
Time Frame: 3 months
UPDRS subscales
3 months
Motor function
Time Frame: 3 months
UPDRS subscales
3 months
Brain metabolites
Time Frame: 3 months
Magnetic Resonance spectroscopy (MRS)
3 months
Cognitive function
Time Frame: 3 months
Montreal Cognitive Assessment (MoCA)
3 months
Mood
Time Frame: 3 months
Beck Depression Inventory (BDI)
3 months
Disease biomarkers
Time Frame: 3 months
Blood biomarker levels
3 months
Safety
Time Frame: 3 months
Number of adverse events
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

Edison Pharmaceuticals Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (Estimate)

August 15, 2013

Study Record Updates

Last Update Posted (Estimate)

September 19, 2016

Last Update Submitted That Met QC Criteria

September 16, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIPD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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