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

Biogen1 site in 1 country44 target enrollmentDecember 2011

ConditionsHearing Loss, Sensorineural

InterventionsPlacebo PF-04958242

DrugsPF-04958242 Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Hearing Loss, Sensorineural
Sponsor: Biogen
Enrollment: 44
Locations: 1
Primary Endpoint: Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

February 2013

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Placebo

Intervention: Placebo

PF-04958242

Intervention: PF-04958242

Outcomes

Primary Outcomes

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

Time Frame: 1 hour

Secondary Outcomes

Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz(5 hours)
Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score(1 hour, 5 hours)
Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing(1 hour, 5 hours)
Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale(1 hour, 5 hours)
Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose.(45 min, 1 hour, 5 hours)