A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT01923584 |
Recruitment Status :
Completed
First Posted : August 15, 2013
Last Update Posted : September 19, 2016
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Condition or disease | Intervention/treatment | Phase |
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Parkinson's Disease | Drug: EPI-743 400mg Drug: EPI-743 200mg | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease |
Study Start Date : | September 2013 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: EPI-743 400mg
EPI-743 at a dose of 400 mg three times daily
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Drug: EPI-743 400mg |
Active Comparator: EPI-743 200mg
EPI-743 at a dose of 200 mg three times daily
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Drug: EPI-743 200mg |
- Visual function [ Time Frame: 3 months ]electroretinogram and color vision
- Neurologic function [ Time Frame: 3 months ]UPDRS subscales
- Motor function [ Time Frame: 3 months ]UPDRS subscales
- Brain metabolites [ Time Frame: 3 months ]Magnetic Resonance spectroscopy (MRS)
- Cognitive function [ Time Frame: 3 months ]Montreal Cognitive Assessment (MoCA)
- Mood [ Time Frame: 3 months ]Beck Depression Inventory (BDI)
- Disease biomarkers [ Time Frame: 3 months ]Blood biomarker levels
- Safety [ Time Frame: 3 months ]Number of adverse events

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923584
United States, Florida | |
University of South Florida | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Theresa Zesiewicz, MD | University of South Florida |
Responsible Party: | University of South Florida |
ClinicalTrials.gov Identifier: | NCT01923584 |
Other Study ID Numbers: |
EPIPD |
First Posted: | August 15, 2013 Key Record Dates |
Last Update Posted: | September 19, 2016 |
Last Verified: | September 2016 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders |
Neurodegenerative Diseases Ubiquinone Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |