Overview

Study of BGG492 in Patients With Chronic Subjective Tinnitus

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the efficacy of a two week treatment with BGG492 in patients with chronic subjective Tinnitus.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Criteria
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