AM-101 in the Treatment of Acute Tinnitus 3

NCT02040194 | Completed Phase 3

• 1 other identifier: AM-101-CL-12-02
• Study Type: interventional
• Target: 893
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months or within the last \>3 to 6 months.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (3)

• Efficacy endpoint - alternate primary efficacy endpoints: Tinnitus Functional Index (TFI)

  Improvement in TFI total score

  Baseline to Day 84

• Efficacy endpoint - alternate primary efficacy endpoints: Patient-reported Tinnitus loudness on a Numerical Rating Scale (TLQ NRS loudest)

  Improvement in TLQ NRS loudest

  Baseline to Day 84

• Safety endpoint: Hearing threshold

  Occurrence of deterioration in hearing threshold \>= 15 decibel (dB) at the average of two contiguous test frequencies (air conduction) in the treated ear(s)

  Baseline to Day 35

Secondary Outcomes (8)

• Efficacy endpoint - TFI

  Baseline to Day 10 and Day 35

• Efficacy endpoint - TLQ NRS loudest

  Baseline to Day 10 and Day 35

• Efficacy endpoint - patient-reported tinnitus annoyance (TAQ NRS worst)

  Baseline to Day10, Day 35 and Day 84

• Efficacy endpoint - TFI sleep score

  Baseline to Day10, Day 35 and Day 84

• Efficacy endpoint - Patient global impression of change in tinnitus severity (PGIC Tinnitus)

  at Day10, Day 35 and Day 84

Study Arms (2)

AM-101 injection

EXPERIMENTAL

AM-101

Drug: AM-101

Placebo injection

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AM-101 DRUG

AM-101 gel for intratympanic injection

AM-101 injection

Placebo DRUG

Placebo gel for intratympanic injection

Placebo injection

Eligibility Criteria

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

You may qualify if:

• Persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer than 3 months (Stratum A) or between \>3 months and 6 months (Stratum B) prior to randomization, as documented by medical report or by documented medical history. Upon implementation of protocol amendment 6, subjects with tinnitus following traumatic cochlear injury will only be eligible if they are affected only unilaterally.
• Age ≥ 18 years and ≤ 75 years;
• Negative pregnancy test (woman of childbearing potential);
• Willing and able to use adequate hearing protection, respectively to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
• Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed.

You may not qualify if:

• Fluctuating tinnitus;
• Intermittent tinnitus;
• Tinnitus resulting from traumatic head or neck injury;
• Presence of chronic tinnitus;
• Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
• History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma;
• Ongoing acute or chronic otitis media or otitis externa;
• Other treatment of tinnitus for the study duration;
• Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction;
• Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
• Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months;
• Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization.

Sponsors & Collaborators

• Auris Medical AG: lead

Study Sites (1)

Please check the study webpage below for a study site list

Munich, Germany

Location

Related Links

• Link to Result entry in clinicaltrialsregister.eu

MeSH Terms

Conditions

Tinnitus

Interventions

PDCD5 protein, rat

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2014
• Primary Completion: December 28, 2017
• Study Completion: December 28, 2017
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

DE (1)