A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2013
CompletedFirst Posted
Study publicly available on registry
August 15, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedSeptember 19, 2016
September 1, 2016
2.2 years
August 13, 2013
September 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Visual function
electroretinogram and color vision
3 months
Secondary Outcomes (7)
Neurologic function
3 months
Motor function
3 months
Brain metabolites
3 months
Cognitive function
3 months
Mood
3 months
- +2 more secondary outcomes
Study Arms (2)
EPI-743 400mg
ACTIVE COMPARATOREPI-743 at a dose of 400 mg three times daily
EPI-743 200mg
ACTIVE COMPARATOREPI-743 at a dose of 200 mg three times daily
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Parkinson's disease
- Age 40 - 75
- Ambulatory with or without assistance
- Hoehn and Yahr Scale score of 1 - 3
- Patient able to consent and comply with protocol requirements
- Abstention from use of Coenzyme Q10, vitamin E, Azilect and Idebenone two weeks prior to enrollment and during course of treatment with EPI-743
You may not qualify if:
- Allergy to EPI-743 or sesame oil
- Allergy to vitamin E
- Clinical history of bleeding or abnormal baseline PT/PTT
- Diagnosis of any other neurologic disease
- Malignancy within past two years
- Pregnant or plans to become pregnant
- Concomitant ophthalmologic disease
- History of stroke
- History of brain surgery
- Inability to undergo MRI scan or MRS
- Hepatic insufficiency with LFTs greater than two times upper limit of normal
- Renal insufficiency requiring dialysis
- End stage cardiac failure
- Fat malabsorption syndromes precluding drug absorption
- Use of anticoagulant medications, azilect
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- Edison Pharmaceuticals Inccollaborator
Study Sites (1)
University of South Florida
Tampa, Florida, 33612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Theresa Zesiewicz, MD
University of South Florida
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2013
First Posted
August 15, 2013
Study Start
September 1, 2013
Primary Completion
December 1, 2015
Study Completion
June 1, 2016
Last Updated
September 19, 2016
Record last verified: 2016-09