AM-101 in the Treatment of Acute Tinnitus 2
Condition: Tinnitus
MeSH terms: Tinnitus
Intervention: AM-101; Placebo
Intervention description: AM-101 gel for intratympanic injection; Placebo gel for intratympanic injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 343.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility 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 (≥ 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.