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Completed

NCT Number: NCT01518920

A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss

The objective of this study is to examine the safety, tolerability, and effects on hearing thresholds of two single doses of PF-04958242 and placebo in subjects with age-related hearing loss.

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Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Anaheim, California, United States

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About this study

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects must have a current diagnosis of age related sensorineural hearing loss in the range of 30-60 dB, averaged over 2 and 4 kHz in at least one ear.
  • Subjects must have symmetric hearing loss
  • Subjects who can read, speak and comprehend English.

Exclusion criteria

  • Subjects who have a history of sudden hearing loss and history or diagnosis of rapidly progressive idiopathic hearing loss
  • Subjects who have hearing disorders other than age related sensorineural hearing loss
  • Subjects with moderate or greater tinnitus
  • Pregnant females; breastfeeding females; females of childbearing potential

Treatment and study plan

PF-04958242

Drug

PF-04958242 0.35 mg oral solution

Placebo

Drug

Placebo oral solution

Primary outcomes

  1. Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz

    Time frame: 1 hour

Secondary outcomes

  1. Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz

    Time frame: 5 hours

  2. Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score

    Time frame: 1 hour, 5 hours

  3. Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing

    Time frame: 1 hour, 5 hours

  4. Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale

    Time frame: 1 hour, 5 hours

  5. Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose.

    Time frame: 45 min, 1 hour, 5 hours

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-04958242 In Subjects With Age-Related Sensorineural Hearing Loss

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 26, 2012
Registry last updated
Nov 21, 2019

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

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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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