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

University of South Florida

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: EPI-743 200mg; Drug: EPI-743 400mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01923584

EPIPD

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

EPI-743 400mg

Active Comparator group

Description:

EPI-743 at a dose of 400 mg three times daily

Treatment:

Drug: EPI-743 400mg

EPI-743 200mg

Active Comparator group

Description:

EPI-743 at a dose of 200 mg three times daily

Treatment:

Drug: EPI-743 200mg