Study of BGG492 in Patients With Chronic Subjective Tinnitus

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Subjective Tinnitus

Treatments: Drug: BGG492A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01302873

2010-022166-27 (EudraCT Number)

CBGG492A2210

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

BGG492

Experimental group

Treatment:

Drug: BGG492A

Drug: BGG492A

Placebo

Placebo Comparator group

Treatment:

Drug: BGG492A

Drug: BGG492A