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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01923584

Enrollment

Registered

2013-08-15

Start date

2013-09-30

Completion date

2016-06-30

Last updated

2016-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Brief summary

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

Interventions

DRUGEPI-743 400mg

DRUGEPI-743 200mg

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Visual function	3 months	electroretinogram and color vision

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026