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

Biogen

Status and phase: Completed; Phase 1

Conditions: Hearing Loss, Sensorineural

Treatments: Drug: PF-04958242; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01518920

B1701005

Details and patient eligibility

About

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.

Full description

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

Enrollment: 44 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

44 participants in 2 patient groups, including a placebo group

PF-04958242

Experimental group

Treatment:

Drug: PF-04958242

Drug: PF-04958242

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo