A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease
NCT ID: NCT01923584
Last Updated: 2016-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2013-09-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EPI-743 400mg
EPI-743 at a dose of 400 mg three times daily
EPI-743 400mg
EPI-743 200mg
EPI-743 at a dose of 200 mg three times daily
EPI-743 200mg
Interventions
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EPI-743 400mg
EPI-743 200mg
Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
75 Years
ALL
No
Sponsors
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Edison Pharmaceuticals Inc
INDUSTRY
University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Theresa Zesiewicz, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida
Tampa, Florida, United States
Countries
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Other Identifiers
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EPIPD
Identifier Type: -
Identifier Source: org_study_id
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