Skip to main content
OpenTrials
Completed

NCT Number: NCT01302873

Study of BGG492 in Patients With Chronic Subjective Tinnitus

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Subjective Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BGG492A

Drug

Primary outcomes

  1. Change in tinnitus loudness using a visual analogue scale (VAS)

    Time frame: after 15 days of treatment

  2. Change in Clinical status of tinnitus (patients' reaction to tinnitus) using the TBF-12 (Tinnitus Impairment Questionnaire)

    Time frame: after 15 days of treatment

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 24, 2011
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.