Study of BGG492 in Patients With Chronic Subjective Tinnitus

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: February 7, 2011
Last updated: April 24, 2012
Last verified: April 2012

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

Condition Intervention Phase
Chronic Subjective Tinnitus
Drug: BGG492A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in tinnitus loudness using a visual analogue scale (VAS) [ Time Frame: after 15 days of treatment ] [ Designated as safety issue: No ]
  • Change in Clinical status of tinnitus (patients' reaction to tinnitus) using the TBF-12 (Tinnitus Impairment Questionnaire) [ Time Frame: after 15 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGG492 Drug: BGG492A
Placebo Comparator: Placebo Drug: BGG492A


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Please refer to this study by its identifier: NCT01302873

Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Lepzig, Germany
Novartis Investigative Site
Groningen, Netherlands, 9700
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01302873     History of Changes
Other Study ID Numbers: CBGG492A2210, 2010-022166-27
Study First Received: February 7, 2011
Last Updated: April 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Switzerland: Swissmedic

Keywords provided by Novartis:
AMPA Receptor antagonist

Additional relevant MeSH terms:
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on April 16, 2014