- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01302873
Study of BGG492 in Patients With Chronic Subjective Tinnitus
March 20, 2017 updated by: Novartis Pharmaceuticals
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
This study will assess the efficacy of a two week treatment with BGG492 in patients with chronic subjective Tinnitus.
Study Overview
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 10117
- Novartis Investigative Site
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Frankfurt, Germany
- Novartis Investigative Site
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Lepzig, Germany
- Novartis Investigative Site
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Groningen, Netherlands, 9700
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Experimental: BGG492
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in tinnitus loudness using a visual analogue scale (VAS)
Time Frame: after 15 days of treatment
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after 15 days of treatment
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Change in Clinical status of tinnitus (patients' reaction to tinnitus) using the TBF-12 (Tinnitus Impairment Questionnaire)
Time Frame: after 15 days of treatment
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after 15 days of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
February 7, 2011
First Submitted That Met QC Criteria
February 22, 2011
First Posted (Estimate)
February 24, 2011
Study Record Updates
Last Update Posted (Actual)
March 22, 2017
Last Update Submitted That Met QC Criteria
March 20, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBGG492A2210
- 2010-022166-27 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Subjective Tinnitus
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Philipps University Marburg Medical CenterLinkoeping University; Eriksholm Research Centre; University Hospital of Gießen...CompletedTinnitus | Subjective Tinnitus | Chronic TinnitusGermany
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State University of New York at BuffaloUniversity at BuffaloCompletedTinnitus, Subjective | Tinnitus | Noise Induced Tinnitus | Tinnitus, Objective | Tinnitus Aggravated | Tinnitus, Pulsatile | Tinnitus, Spontaneous Oto-Acoustic Emission | Tinnitus, Clicking | Tinnitus, Tensor Tympani InducedUnited States
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Technical University of DenmarkCompleted
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Otonomy, Inc.CompletedSubjective TinnitusUnited States, United Kingdom, Germany, Poland
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Otonomy, Inc.Completed
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Cairo UniversityCompleted
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Medical University of LodzCompleted
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Pansatori GmbHCompetence Center for Medical Devices GmbHUnknown
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Tel-Aviv Sourasky Medical CenterCompleted
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Eye & ENT Hospital of Fudan UniversityUnknown