Study of BGG492 in Patients With Chronic Subjective Tinnitus

Phase 2

Completed

• Conditions: Chronic Subjective Tinnitus
• Interventions: Drug: BGG492A

• Registration Number: NCT01302873
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-24
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	BGG492A	-
BGG492	BGG492A	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇳🇱 Groningen, Netherlands