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AM-101 in the Treatment of Acute Tinnitus 3 (TACTT3)

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ClinicalTrials.gov Identifier: NCT02040194
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc. ( Auris Medical AG )

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.

Condition or disease Intervention/treatment Phase
Tinnitus Drug: AM-101 Drug: Placebo Phase 3

Detailed Description:
This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratympanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months (Stratum A), or between >3 and 6 months (Stratum B) from onset).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 893 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3
Study Start Date : January 2014
Actual Primary Completion Date : December 28, 2017
Actual Study Completion Date : December 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: AM-101 injection
AM-101
Drug: AM-101
AM-101 gel for intratympanic injection

Placebo Comparator: Placebo injection
Placebo
Drug: Placebo
Placebo gel for intratympanic injection




Primary Outcome Measures :
  1. Efficacy endpoint - alternate primary efficacy endpoints: Tinnitus Functional Index (TFI) [ Time Frame: Baseline to Day 84 ]
    Improvement in TFI total score

  2. Efficacy endpoint - alternate primary efficacy endpoints: Patient-reported Tinnitus loudness on a Numerical Rating Scale (TLQ NRS loudest) [ Time Frame: Baseline to Day 84 ]
    Improvement in TLQ NRS loudest

  3. Safety endpoint: Hearing threshold [ Time Frame: Baseline to Day 35 ]
    Occurrence of deterioration in hearing threshold >= 15 decibel (dB) at the average of two contiguous test frequencies (air conduction) in the treated ear(s)


Secondary Outcome Measures :
  1. Efficacy endpoint - TFI [ Time Frame: Baseline to Day 10 and Day 35 ]
    Improvement in TFI total score

  2. Efficacy endpoint - TLQ NRS loudest [ Time Frame: Baseline to Day 10 and Day 35 ]
    Improvement in patient-reported tinnitus loudness

  3. Efficacy endpoint - patient-reported tinnitus annoyance (TAQ NRS worst) [ Time Frame: Baseline to Day10, Day 35 and Day 84 ]
    Improvement in TAQ NRS worst

  4. Efficacy endpoint - TFI sleep score [ Time Frame: Baseline to Day10, Day 35 and Day 84 ]
    Improvement in TFI sleep score. The subscale "sleep" will be evaluated only for subjects with a TFI Sleep score greater than 0 at baseline.

  5. Efficacy endpoint - Patient global impression of change in tinnitus severity (PGIC Tinnitus) [ Time Frame: at Day10, Day 35 and Day 84 ]
    Patient global impression of change in tinnitus severity

  6. Safety endpoint - Hearing threshold [ Time Frame: Baseline to Day 1, Day 2, Day 10 and Day 84 ]
    Occurrence of deterioration in hearing threshold >= 15 dB at the average of two contiguous test frequencies in the treated ear(s)

  7. Safety endpoint - Hearing threshold [ Time Frame: Baseline to Day 1, Day 2, Day 10 and Day 84 ]
    Difference in occurrence of deterioration in hearing threshold >= 15 dB at the average of two contiguous test frequencies between the treated and untreated contralateral ear (subjects with unilaterally treated tinnitus only)

  8. Safety endpoint - AEs and SAEs [ Time Frame: Up to Day 84 ]
    Occurence and severity of adverse events (AEs) and serious adverse Events (SAEs), differentiated by relatedness, and by treatment-emergence and procedure-emergence



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Age ≥ 18 years and ≤ 75 years;
  3. Negative pregnancy test (woman of childbearing potential);
  4. 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;
  5. Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  1. Fluctuating tinnitus;
  2. Intermittent tinnitus;
  3. Tinnitus resulting from traumatic head or neck injury;
  4. Presence of chronic tinnitus;
  5. Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
  6. History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma;
  7. Ongoing acute or chronic otitis media or otitis externa;
  8. Other treatment of tinnitus for the study duration;
  9. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction;
  10. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
  11. 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;
  12. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization.

Other protocol-defined exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040194


Locations
Germany
Please check the study webpage below for a study site list
Munich, Germany
Sponsors and Collaborators
Auris Medical AG

Responsible Party: Auris Medical AG
ClinicalTrials.gov Identifier: NCT02040194     History of Changes
Other Study ID Numbers: AM-101-CL-12-02
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms