Study of BGG492 in Patients With Chronic Subjective Tinnitus

Study Overview
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Brief Summary
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This study will assess the efficacy of a two week treatment with BGG492 in patients with chronic subjective Tinnitus.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo- Controlled, Cross-over, Proof of Concept Study Comparing the Effects of Both Single Dose and Repeated Dosing Treatment for 2 Weeks of BGG492 in Patients With Chronic Subjective Tinnitus

Conditions
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Chronic Subjective Tinnitus

Intervention / Treatment
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* Drug: BGG492A
* Drug: BGG492A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with THI (Tinnitus Handicap Inventory) severity grade 3, 4 or 5 (moderate, severe or catastrophic), chronic (> 6 months and < 36 months) subjective tinnitus Willing to abstain from activities that require focused attention, e.g. driving a car or other vehicles, operating machines or engaging in potentially dangerous activities that require focused attention and intact physical balance Willing and able to refrain from engaging in activities or work involving loud noise exposure Exclusion Criteria: Patients diagnosed with tinnitus of THI severity grade equal to 2 or 1 Patients with diagnosis of intermittent or pulsatile tinnitus Patients who have tinnitus as a concomitant symptom of a treatable otological disease (such as otitis media, Menière's disease, otosclerosis), neurological tumors or/and have temporo-mandibular joint disorders Patients with a history of frequent middle ear infections (> 3 infections per year during the last 3 years) Patients with diagnosed anxiety disorders, depression, schizophrenia or other significant psychiatric diseases requiring current drug treatment or patients who required treatment in the previous 3 months for these diseases. Patients with current unilateral or bilateral hearing loss of 75 dB or more in one or more tested frequencies (125 Hz, 250 Hz, 1 kHz, 2 kHz, 4 kHz, 6 kHz, 8 kHz) Patients with Vestibular Schwannoma Patients with a cochlear implant Patients with regular intake of central nervous system acting drugs for the treatment of tinnitus in the previous 6 months prior to initial dosing Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGG492<br> | Drug: BGG492A<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: BGG492A<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tinnitus loudness using a visual analogue scale (VAS) |  | after 15 days of treatment | 
| Change in Clinical status of tinnitus (patients' reaction to tinnitus) using the TBF-12 (Tinnitus Impairment Questionnaire) |  | after 15 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinnitus, AMPA Receptor antagonist