A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease
Status: | Completed |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 40 - 75 |
Updated: | 3/16/2015 |
Start Date: | September 2013 |
End Date: | March 2015 |
Contact: | Kevin Allison |
Email: | kalliso1@health.usf.edu |
Phone: | 813-974-5909 |
The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's
disease.
disease.
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
We found this trial at
1
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