Chronic Subjective Tinnitus Clinical Trial
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
| Verified date | March 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will assess the efficacy of a two week treatment with BGG492 in patients with chronic subjective Tinnitus.
| Status | Completed |
| Enrollment | 96 |
| Est. completion date | January 2012 |
| Est. primary completion date | January 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Lepzig | |
| Netherlands | Novartis Investigative Site | Groningen |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Germany, Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in tinnitus loudness using a visual analogue scale (VAS) | after 15 days of treatment | ||
| Primary | Change in Clinical status of tinnitus (patients' reaction to tinnitus) using the TBF-12 (Tinnitus Impairment Questionnaire) | after 15 days of treatment |