AM-101 in the Treatment of Acute Tinnitus 2 (TACTT2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Auris Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01803646
First received: March 1, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Tinnitus
Drug: AM-101
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2

Resource links provided by NLM:


Further study details as provided by Auris Medical, Inc.:

Primary Outcome Measures:
  • Tinnitus loudness [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    Improvement in tinnitus loudness

  • Tinnitus questionnaire [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    Improvement in tinnitus questionnaire

  • Hearing threshold [ Time Frame: Day 35 ] [ Designated as safety issue: Yes ]
    Occurrence of deterioration in hearing threshold in the treated ear(s)


Secondary Outcome Measures:
  • Tinnitus loudness [ Time Frame: Up to Day 35 ] [ Designated as safety issue: No ]
    Improvement in tinnitus loudness

  • Tinnitus questionnaire [ Time Frame: Up to Day 35 ] [ Designated as safety issue: No ]
    Improvement in tinnitus questionnaire

  • Hearing threshold [ Time Frame: Up to Day 84 ] [ Designated as safety issue: Yes ]
    Difference in occurrence of deterioration in hearing threshold in the treated ear(s)

  • Adverse events and serious adverse events [ Time Frame: Throughout subject study participation ] [ Designated as safety issue: Yes ]
    Occurence and severity of adverse events and serious adverse events


Estimated Enrollment: 330
Study Start Date: February 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratymanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months from onset).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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 prior to randomization
  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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803646

Contacts
Contact: Medpace +1.513.579.9911 auris-trials@medpace.com

Locations
United States, Ohio
Medpace Recruiting
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Auris Medical, Inc.
  More Information

No publications provided

Responsible Party: Auris Medical, Inc.
ClinicalTrials.gov Identifier: NCT01803646     History of Changes
Other Study ID Numbers: AM-101-CL-12-01
Study First Received: March 1, 2013
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on August 01, 2014