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Protective Effects of EPI-743 on Noise-Induced Hearing Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02257983
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
PTC Therapeutics

Brief Summary:
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.

Condition or disease Intervention/treatment Phase
Noise-induced Hearing Loss Drug: EPI-743 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss
Actual Study Start Date : October 31, 2014
Actual Primary Completion Date : November 30, 2015
Actual Study Completion Date : February 29, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: EPI-743
EPI-743 400 mg P.O. TID
Drug: EPI-743
EPI-743 (2 capsules 200 mg each) taken at a dose of 400 mg P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
Other Names:
  • VincerinoneTM
  • EPI743

Placebo Comparator: Placebo
Sesame Oil, NF in sealed gelatin capsules to match the test product
Drug: Placebo
2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
Other Name: Matching placebo




Primary Outcome Measures :
  1. Pure tone audiometry [ Time Frame: 9 days ]

Secondary Outcome Measures :
  1. Time to recovery following acute noise exposure [ Time Frame: 9 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults ages 18-30
  • Abstention from use of Idebenone, CoQ10, Vitamin E and foods or beverages at least 30 days prior to treatment initiation
  • Non-smokers
  • Abstention from alcohol from day 0 and throughout the duration of study
  • Normal audiology exam
  • Subject must be able to swallow size 0 capsules

Exclusion Criteria:

  • Allergy to EPI-743 or sesame oil or nuts
  • Any medical disordere that would prevent subject participation
  • Any prescription meds other than for contraception or seasonal allergies
  • Any significant patient medical history (cancer, cardiovascular, pulmonary, cognitive, ADHD, hx. of migraines, neurological, kidney)
  • Fat malabsorption syndromes
  • Anticoagulation thereapy within 30 days of enrollment

Information from the National Library of Medicine

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): NCT02257983


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
PTC Therapeutics
Investigators
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Principal Investigator: Colleen Le Prell, Ph.D University of Florida
Additional Information:
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Responsible Party: PTC Therapeutics
ClinicalTrials.gov Identifier: NCT02257983    
Other Study ID Numbers: EPI743-14-026
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Keywords provided by PTC Therapeutics:
hearing
noise
oxidative stress
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Hearing Loss, Sensorineural
Ubiquinone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs