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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Collaborator: Edison Pharmaceuticals Inc
• Treatments: Ubiquinone

Criteria

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