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

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ClinicalTrials.gov Identifier: NCT01923584
Recruitment Status : Completed
First Posted : August 15, 2013
Last Update Posted : September 19, 2016
Sponsor:
Collaborator:
Edison Pharmaceuticals Inc
Information provided by (Responsible Party):
University of South Florida

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: EPI-743 400mg Drug: EPI-743 200mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease
Study Start Date : September 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: EPI-743 400mg
EPI-743 at a dose of 400 mg three times daily
 Drug: EPI-743 400mg
Active Comparator: EPI-743 200mg
EPI-743 at a dose of 200 mg three times daily
 Drug: EPI-743 200mg


Outcome Measures
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Primary Outcome Measures :
  1. Visual function [ Time Frame: 3 months ]
    electroretinogram and color vision


Secondary Outcome Measures :
  1. Neurologic function [ Time Frame: 3 months ]
    UPDRS subscales

  2. Motor function [ Time Frame: 3 months ]
    UPDRS subscales

  3. Brain metabolites [ Time Frame: 3 months ]
    Magnetic Resonance spectroscopy (MRS)

  4. Cognitive function [ Time Frame: 3 months ]
    Montreal Cognitive Assessment (MoCA)

  5. Mood [ Time Frame: 3 months ]
    Beck Depression Inventory (BDI)

  6. Disease biomarkers [ Time Frame: 3 months ]
    Blood biomarker levels

  7. Safety [ Time Frame: 3 months ]
    Number of adverse events


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923584


Locations
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United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Edison Pharmaceuticals Inc
Investigators
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Principal Investigator: Theresa Zesiewicz, MD University of South Florida
More Information
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01923584    
Other Study ID Numbers: EPIPD
First Posted: August 15, 2013    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
 Neurodegenerative Diseases
Ubiquinone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs