Clinical trial NCT01518920: A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hearing Loss, Sensorineural
Keywords: Age related sensorineural hearing loss
PF-04958242
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz
timeFrame: 1 hour
Secondary outcomes:
measure: Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz
timeFrame: 5 hours
measure: Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score
timeFrame: 1 hour, 5 hours
measure: Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing
timeFrame: 1 hour, 5 hours
measure: Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale
timeFrame: 1 hour, 5 hours
measure: Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose.
timeFrame: 45 min, 1 hour, 5 hours
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Bednar MM, DeMartinis N, Banerjee A, Bowditch S, Gaudreault F, Zumpano L, Lin FR. The Safety and Efficacy of PF-04958242 in Age-Related Sensorineural Hearing Loss: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Jul;141(7):607-13. doi: 10.1001/jamaoto.2015.0791.