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Trial record 3 of 7 for:    am101

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

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: 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 )

Tracking Information
First Submitted Date  ICMJE January 14, 2014
First Posted Date  ICMJE January 20, 2014
Last Update Posted Date January 16, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date December 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Efficacy endpoint - alternate primary efficacy endpoints: Tinnitus Functional Index (TFI) [ Time Frame: Baseline to Day 84 ]
    Improvement in TFI total score
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2014)
  • Tinnitus loudness [ Time Frame: Day 84 ]
    Improvement in tinnitus loudness
  • Hearing threshold [ Time Frame: Day 35 ]
    Occurrence of deterioration in hearing threshold in the treated ear(s)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Efficacy endpoint - TFI [ Time Frame: Baseline to Day 10 and Day 35 ]
    Improvement in TFI total score
  • Efficacy endpoint - TLQ NRS loudest [ Time Frame: Baseline to Day 10 and Day 35 ]
    Improvement in patient-reported tinnitus loudness
  • Efficacy endpoint - patient-reported tinnitus annoyance (TAQ NRS worst) [ Time Frame: Baseline to Day10, Day 35 and Day 84 ]
    Improvement in TAQ NRS worst
  • 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.
  • 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
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2014)
  • Responders [ Time Frame: Day 84 ]
    Proportion of Responders
  • Tinnitus questionnaires [ Time Frame: Up to Day 84 ]
    Improvement in tinnitus questionnaires
  • Tinnitus loudness [ Time Frame: Up to Day 35 ]
    Improvement in tinnitus loudness
  • Hearing threshold [ Time Frame: Up to Day 84 ]
    Difference in occurrence of deterioration in hearing threshold in the treated ear(s)
  • Adverse events and serious adverse events [ Time Frame: Up to Day 84 ]
    Occurence and severity of adverse events and serious adverse events
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 3
Official Title  ICMJE Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3
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.
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  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 * Not Provided

*   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: January 12, 2018)
893
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2014)
600
Actual Study Completion Date  ICMJE December 28, 2017
Actual Primary Completion Date December 28, 2017   (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 (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.

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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02040194
Other Study ID Numbers  ICMJE AM-101-CL-12-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Auris Medical, Inc. ( Auris Medical AG )
Study Sponsor  ICMJE Auris Medical AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Auris Medical, Inc.
Verification Date January 2018

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