Back to resultsA Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EPI-743 400mg
EPI-743 200mg
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
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
Sites / Locations
- University of South Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
EPI-743 400mg
EPI-743 200mg
Arm Description
EPI-743 at a dose of 400 mg three times daily
EPI-743 at a dose of 200 mg three times daily
Outcomes
Primary Outcome Measures
Visual function
electroretinogram and color vision
Secondary Outcome Measures
Neurologic function
UPDRS subscales
Motor function
UPDRS subscales
Brain metabolites
Magnetic Resonance spectroscopy (MRS)
Cognitive function
Montreal Cognitive Assessment (MoCA)
Mood
Beck Depression Inventory (BDI)
Disease biomarkers
Blood biomarker levels
Safety
Number of adverse events
Full Information
NCT ID
NCT01923584
First Posted
August 13, 2013
Last Updated
September 16, 2016
Sponsor
University of South Florida
Collaborators
Edison Pharmaceuticals Inc
1. Study Identification
Unique Protocol Identification Number
NCT01923584
Brief Title
A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease
Official Title
A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
Edison Pharmaceuticals Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EPI-743 400mg
Arm Type
Active Comparator
Arm Description
EPI-743 at a dose of 400 mg three times daily
Arm Title
EPI-743 200mg
Arm Type
Active Comparator
Arm Description
EPI-743 at a dose of 200 mg three times daily
Intervention Type
Drug
Intervention Name(s)
EPI-743 400mg
Intervention Type
Drug
Intervention Name(s)
EPI-743 200mg
Primary Outcome Measure Information:
Title
Visual function
Description
electroretinogram and color vision
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Neurologic function
Description
UPDRS subscales
Time Frame
3 months
Title
Motor function
Description
UPDRS subscales
Time Frame
3 months
Title
Brain metabolites
Description
Magnetic Resonance spectroscopy (MRS)
Time Frame
3 months
Title
Cognitive function
Description
Montreal Cognitive Assessment (MoCA)
Time Frame
3 months
Title
Mood
Description
Beck Depression Inventory (BDI)
Time Frame
3 months
Title
Disease biomarkers
Description
Blood biomarker levels
Time Frame
3 months
Title
Safety
Description
Number of adverse events
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Zesiewicz, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease
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