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Completed

NCT Number: NCT04829214

OTO-313 in Subjects With Unilateral Subjective Tinnitus

The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HNO Praxis - Marianne Grohe, Cologne, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject has early-onset subjective unilateral tinnitus that is persistent (consistently aware of their tinnitus throughout much of the waking day).
  • Subject is able to use the 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.

Exclusion criteria

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

Treatment and study plan

OTO-313

Drug

Single intratympanic injection

Placebo

Drug

Single intratympanic injection

Primary outcomes

  1. Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8

    Time frame: Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder")

    The TFI is a validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate a greater problem with tinnitus. A responder is considered as any subject with at least a 13-point improvement from Baseline on the (TFI). This responder analysis required both Week 4 and Week 8 to have a 13-point improvement from Baseline.

Secondary outcomes

  1. Change From Baseline in Daily Tinnitus Loudness at Week 8

    Time frame: The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8.

    Numerical rating scale (NRS) from 0 (No Tinnitus) to 10 (Extremely Loud Tinnitus) collected every day. Post-baseline weekly NRS scores will be calculated as the average score of all recorded diary entries within each study week.

  2. Change From Baseline in Daily Tinnitus Annoyance at Week 8

    Time frame: The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8

    Numerical rating scale from 0 (Not Annoying) to 10 (Extremely Annoying) collected every day. Post-baseline weekly NRS scores will be calculated as the average score of all recorded diary entries within each study week.

  3. Patient Global Impression of Change at Week 8

    Time frame: Week 8 reported here

    Change in overall tinnitus status as perceived by the subject as assessed at the Week 8 visit. Subjects were asked, "Since the beginning of the clinical study, how would you rate your tinnitus?" and had the choice to answer from very much worse (-3) to very much improved (3). The mean change from baseline at Week 8 is reported here.

Other outcomes

  1. Otoscopic Examinations - Presence of Perforation in the Treated Ear at Week 16 (Final Visit)

    Time frame: After dosing (Baseline) up to end of study (16 Weeks)

    Ear examinations were done at every visit. One of the important safety endpoints is an observation of a perforation in the ear drum that did not heal properly after the injection. Reported here are the Week 16 (final visit) results.

Sponsors and collaborators

Lead sponsor

Otonomy, Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase 2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Unilateral Subjective Tinnitus

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 2, 2021
Registry last updated
Jan 6, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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