Clinical trial NCT01302873: Study of BGG492 in Patients With Chronic Subjective Tinnitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Subjective Tinnitus
Keywords: Tinnitus
AMPA Receptor antagonist
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in tinnitus loudness using a visual analogue scale (VAS)
timeFrame: after 15 days of treatment
measure: Change in Clinical status of tinnitus (patients' reaction to tinnitus) using the TBF-12 (Tinnitus Impairment Questionnaire)
timeFrame: after 15 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Lepzig
country: Germany
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Kucher K, Johns D, Wagner F, Abd-Elaziz K, Derne C, Sverdlov O, Pfister CU, Langguth B. Efficacy and safety of single- and repeated-selurampanel dosing for 2 weeks in patients with chronic subjective tinnitus: Results of a randomized, double-blind, placebo-controlled, cross-over, proof-of-concept phase IIa study. Prog Brain Res. 2021;260:423-440. doi: 10.1016/bs.pbr.2020.12.004. Epub 2021 Jan 20.