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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923584
• Other study ID #: EPIPD
• Status: Completed
• Phase: Phase 2
• First received: August 13, 2013
• Last updated: September 16, 2016
• Start date: September 2013
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• EPI-743 400mg

• EPI-743 200mg

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Edison Pharmaceuticals Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual function	electroretinogram and color vision	3 months	No
Secondary	Neurologic function	UPDRS subscales	3 months	No
Secondary	Motor function	UPDRS subscales	3 months	No
Secondary	Brain metabolites	Magnetic Resonance spectroscopy (MRS)	3 months	No
Secondary	Cognitive function	Montreal Cognitive Assessment (MoCA)	3 months	No
Secondary	Mood	Beck Depression Inventory (BDI)	3 months	No
Secondary	Disease biomarkers	Blood biomarker levels	3 months	No
Secondary	Safety	Number of adverse events	3 months	Yes