Study of BGG492 in Patients With Chronic Subjective Tinnitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-01-31

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.

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Detailed Description

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Conditions

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Chronic Subjective Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BGG492

Group Type EXPERIMENTAL

BGG492A

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

BGG492A

Intervention Type DRUG

Interventions

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BGG492A

Intervention Type DRUG

BGG492A

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No