Study of BGG492 in Patients With Chronic Subjective Tinnitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01302873
First received: February 7, 2011
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302873

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov 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:
Tinnitus
AMPA Receptor antagonist

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014