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Trial record 4 of 7 for:    am101

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01803646
Recruitment Status : Completed
First Posted : March 4, 2013
Results First Posted : May 29, 2018
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.

Tracking Information
First Submitted Date  ICMJE March 1, 2013
First Posted Date  ICMJE March 4, 2013
Results First Submitted Date  ICMJE January 18, 2018
Results First Posted Date  ICMJE May 29, 2018
Last Update Posted Date May 29, 2018
Study Start Date  ICMJE February 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Efficacy: Change in Patient-reported Tinnitus Loudness Questionnaire (TLQ) Improvement From Baseline to Follow up Visit 3 (FUV3) [ Time Frame: Screening (D-14) versus final follow-up (D83) ]
    Starting at the screening visit (SV), each subject recorded the following numerical rating scales (NRS) throughout the entire study duration: - Tinnitus loudness "at its loudest" within the last 24 hours (Tinnitus Loudness Questionnaire [TLQ] NRSLoudest). Subjects were asked "On a scale from 0 to 10, where 0 represents no tinnitus and 10 represents extremely loud tinnitus, what one number best describes your tinnitus at its loudest in the last 24 hours (including right now)?" TLQ NRSLoudest was collected from SV (D-14) to the evening before FUV3 (D83). The ratings were to be recorded every day before going to sleep on an electronic device. As Baseline the10 ratings of the screening period before the first treatment were averaged. For the FUV3 endpoint, the ratings of the 7 days before FUV3 were averaged.
  • Co-Primary Efficacy: Improvement in Tinnitus Functional Index (TFI) Total Score From Baseline to FUV3 [ Time Frame: D0 (=TV1) versus Day 84 (=FUV3) ]
    The TFI was recorded on an electronic device (electronic patient reported outcome) at Treatment Visit 1 (TV1), before randomization, and at Follow up Visit 1 (FUV1), FUV2 and FUV3. The TFI is a patient reported outcome questionnaire and contains 25 questions. It includes eight subscales: Intrusive, Sense of Control, Cognitive, Sleep, Auditory, Relaxation, Quality of Life, and Emotional. Each question is to be rated on a NRS between 0 and 10 (or 0 to 100%), with a recall period of "over the past week". The TFI total score is considered as valid if there are evaluable answers for at least 19 of the 25 items (76% of items) (Meikle et al. 2012). The repondent's overall TFI score is within a 0-100 range. For the subscales the range is the same. A lower value represents an improvement for all scales. Please refer to the following publicly available link for more information: http://download.lww.com/wolterskluwer_vitalstream_com/PermaLink/EANDH/A/EANDH_2011_09_27_HENRY_200593_SDC15.pdf
  • Safety: Frequency of Subjects With Deterioration of Hearing at Follow up Visit 2 (FUV2) [ Time Frame: Day 35 ]
    Occurence of deterioration of hearing (Air and Bone conduction) in the treated ear at FUV2. Deterioration is defined as a deterioration of hearing threshold of at least 15 dB from Baseline at the average of 2 contiguous frequencies.
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2013)
  • Tinnitus loudness [ Time Frame: Day 90 ]
    Improvement in patient-reported tinnitus loudness (TLQ NRSLoudest) from baseline to Day 90.
  • Deterioration in hearing threshold [ Time Frame: day 30 ]
    Occurrence of deterioration in hearing threshold ≥ 15 decibel (dB) from baseline to Day 30 at the average of two contiguous test frequencies (air conduction) in the treated ear. It will be conducted with air and bone conduction hearing threshold values.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AM-101 in the Treatment of Acute Tinnitus 2
Official Title  ICMJE Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE
  • Drug: AM-101
    AM-101 gel for intratympanic injection
  • Drug: Placebo
    Placebo gel for intratympanic injection
Study Arms  ICMJE
  • Experimental: AM-101 injection
    AM-101
    Intervention: Drug: AM-101
  • Placebo Comparator: Placebo injection
    Placebo
    Intervention: Drug: Placebo
Publications * Staecker H, Morelock M, Kramer T, Chrbolka P, Ahn JH, Meyer T. Safety of Repeated-Dose Intratympanic Injections with AM-101 in Acute Inner Ear Tinnitus. Otolaryngol Head Neck Surg. 2017 Sep;157(3):478-487. doi: 10.1177/0194599817711378. Epub 2017 Jun 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2018)
343
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2013)
300
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (≥ 14 years and ≤ 75 years at selected sites);
  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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01803646
Other Study ID Numbers  ICMJE AM-101-CL-12-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Auris Medical, Inc.
Study Sponsor  ICMJE Auris Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Auris Medical, Inc.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP