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

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: EPI-743 200mg; Drug: EPI-743 400mg

• Registration Number: NCT01923584
• Lead Sponsor: University of South Florida

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-15
• Study Start: 2013-09
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-16
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EPI-743 200mg	EPI-743 200mg	EPI-743 at a dose of 200 mg three times daily
EPI-743 400mg	EPI-743 400mg	EPI-743 at a dose of 400 mg three times daily

Primary Outcome Measures

Name	Time	Method
Visual function	3 months	electroretinogram and color vision

Secondary Outcome Measures

Name	Time	Method
Cognitive function	3 months	Montreal Cognitive Assessment (MoCA)
Mood	3 months	Beck Depression Inventory (BDI)
Disease biomarkers	3 months	Blood biomarker levels
Neurologic function	3 months	UPDRS subscales
Motor function	3 months	UPDRS subscales
Brain metabolites	3 months	Magnetic Resonance spectroscopy (MRS)
Safety	3 months	Number of adverse events

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States