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

Completed · Phase 2

Conditions studied: Parkinson's Disease

In brief

The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's disease.

Key facts

Study ID

NCT01923584

Run by

University of South Florida

People needed

15

Starts

2013-09-01

Expected to finish

2016-06-01

Last updated by the study team

2016-09-19

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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