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Completed

NCT Number: NCT01923584

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

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of South Florida

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

EPI-743 400mg

Drug

EPI-743 200mg

Drug

Primary outcomes

  1. Visual function

    Time frame: 3 months

    electroretinogram and color vision

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Edison Pharmaceuticals Inc

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Aug 15, 2013
Registry last updated
Sep 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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