Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus (TACTT1)

• ClinicalTrials.gov Identifier: NCT01270282
• Recruitment Status: Completed
• First Posted: January 5, 2011
• Last Update Posted: January 26, 2015
• Sponsor: Auris Medical, Inc.
• Information provided by (Responsible Party): Auris Medical, Inc.

Tracking Information

• First Submitted Date: December 30, 2010
• First Posted Date: January 5, 2011
• Last Update Posted Date: January 26, 2015
• Study Start Date: February 2011
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 2, 2012): The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection [ Time Frame: 90 or 104 days ]
• Original Primary Outcome Measures (submitted: January 4, 2011): Change in the minimum masking level in dB from Baseline to Day 90 [ Time Frame: 90 days ]

Current Secondary Outcome Measures (submitted: February 2, 2012)

• Standard audiological evaluations [ Time Frame: 90 or 104 days ]
  Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match
• Questionnaires evaluating the impact of tinnitus [ Time Frame: 90 or 104 days ]
  Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire
• Pharmacokinetic measures [ Time Frame: 3 or 14 days ]

Original Secondary Outcome Measures (submitted: January 4, 2011)

• Standard audiological evaluations [ Time Frame: 90 days ]
  Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match
• Questionnaires evaluating the impact of tinnitus [ Time Frame: 90 days ]
  Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire
• Pharmacokinetic measures [ Time Frame: 3 days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
• Official Title: Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
• Brief Summary: The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Tinnitus

Intervention

• Drug: AM-101 0.81 mg/mL
• Drug: Placebo

Study Arms

• Experimental: AM-101 0.81 mg/mL
  Gel for injection; single or triple injection
  Intervention: Drug: AM-101 0.81 mg/mL
• Placebo Comparator: Placebo
  Gel for injection; single or triple injection
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 22, 2013): 82
• Original Estimated Enrollment (submitted: January 4, 2011): 24
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago.

Exclusion Criteria:

• Tinnitus that is not completely maskable
• Fluctuating tinnitus
• Intermittent tinnitus
• Meniere's Disease
• Ongoing acute or chronic otitis media or otitis externa.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Germany, Poland, United States

Administrative Information

• NCT Number: NCT01270282
• Other Study ID Numbers: AM-101-CL-10-02; AM-101-CL-10-02 ( Other Identifier: Auris Medical )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Auris Medical, Inc.
• Original Responsible Party: Thomas Meyer, PhD, Auris Medical Inc.
• Current Study Sponsor: Auris Medical, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Auris Medical, Inc.
• Verification Date: January 2015