OTO-313 in Subjects With Subjective Tinnitus

NCT03918109 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 313-201901
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 16

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, plasma pharmacokinetics (PK), and exploratory efficacy of OTO-313 administered as an intratympanic injection for the treatment of subjective tinnitus.

Conditions

Tinnitus, Subjective

Keywords

tinnitus, intratympanic injection, gacyclidine

Outcome Measures

Primary Outcomes (2)

• Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ)

  Mean Change from Baseline to End of Study (baseline to Day 29 \[4 weeks after dosing\](Part A) or baseline to Day 57 \[8 weeks after dosing\] (Part B)). in Pure Tone Average Hearing Thresholds; a negative change indicates improvement.

  Up to end of study (Part A - Day 29 [4 weeks after dosing]), (Part B - Day 57 [8 weeks after dosing])

• Otoscopic Examination - Presence of Perforation in the Treated Ear at the End of Study Visit (Day 29 [4 Weeks After Dosing] (Part A) or Day 57 [8 Weeks After Dosing] (Part B)).

  Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum that did not heal properly after the injection.

  Up to end of study (Part A - Day 29 [4 weeks after the injection], Part B - Day 57 [8 weeks after the injection])

Other Outcomes (2)

• Change From Baseline in Tinnitus Functional Index (TFI)

  Up to the End of Study Visit (Part A - Day 29 [4 weeks after the injection]), (Part B - Day 57 [8 weeks after injection])

• Patient Global Impression of Change (PGIC)

  Measured at the end of study visit (Part A - Day 29 [4 weeks after injection]), (Part B - Day 57 [8 weeks after injection]).

Study Arms (2)

OTO-313

EXPERIMENTAL

Drug: OTO-313

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

OTO-313 DRUG

single intratympanic injection of gacyclidine

OTO-313

Placebo DRUG

single intratympanic injection of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has subjective unilateral tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
• Subject is able to use the electronic diary to complete their daily tinnitus ratings
• Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age-related hearing loss; resolved otitis media; ototoxic drug exposure.
• Subject is willing to comply with the protocol and attend all study visits.

You may not qualify if:

• Subject has pulsatile tinnitus, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
• Subject is pregnant or lactating.
• Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline (Day 1) that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.

Sponsors & Collaborators

• Otonomy, Inc.: lead

Study Sites (16)

House Clinic

Los Angeles, California, 90057, United States

Location

California Head & Neck Specialists

San Diego, California, 92121, United States

Location

Colorado ENT and Allergy

Colorado Springs, Colorado, 80909, United States

Location

Silverstein Institute/Ear Research Foundation

Sarasota, Florida, 34239, United States

Location

ChicagoENT

Chicago, Illinois, 60657, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40207, United States

Location

Tandem Clinical Research, LLC

Marrero, Louisiana, 70072, United States

Location

Summit Medical Group

Berkeley Heights, New Jersey, 10882, United States

Location

Dent Neurosciences Research Center

Amherst, New York, 14226, United States

Location

Northwell Health, Hearing & Speech Center

New Hyde Park, New York, 11042, United States

Location

Northwell Health at ENT and Allergy Associates

White Plains, New York, 10605, United States

Location

Charlotte Eye Ear Nose & Throat Associates

Charlotte, North Carolina, 28210, United States

Location

Piedmont Ear, Nose, and Throat Associates

Winston-Salem, North Carolina, 27103, United States

Location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

WVU Medicine

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Otonomy Medical Information Center
• Organization: Otonomy, Inc.

medinfo@otonomy.com

1-844-686-4636

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, multicenter

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 17, 2019
• Study Start: April 4, 2019
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: December 23, 2022
• Results First Posted: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)