Study of BGG492 in Patients With Chronic Subjective Tinnitus

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01302873

Enrollment

Registered

2011-02-24

Start date

2011-01-31

Completion date

2012-01-31

Last updated

2017-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Subjective Tinnitus

Keywords

Tinnitus, AMPA Receptor antagonist

Brief summary

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

Interventions

DRUGBGG492A

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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/

Design outcomes

Primary

Measure	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

Countries

Germany, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026