indication “tinnitus”. condition: patients with chronic subjective tinnitus. MedDRA version: 14.1 Level: PT Classification code 10043882 Term: Tinnitus System Organ Class: 10013993 - Ear and labyrinth disorders
Conditions
Interventions
Product Name: NA
Product Code: BGG492A
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
CAS Number: 912574-69-7
Current Sponsor code: BGG492A
Other descriptive name: NA
Concentration unit: m
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion have to fulfill all of : 1.Written informed consent must be obtained 2.Male and female patients, age 18 to 75 years (included), diagnosed with THI severity grade 3, 4 or 5 (moderate, severe or catastrophic), chronic (lasting > 6 months and 20 bpm) associated with clinical manifestation of postural hypotension. Any patient exhibiting clinical manifestations of postural hypotension should be excluded. Antihypertensive therapy is acceptable if treatment is stable for at least one month prior to start of treatment with study medication. Beta-adrenergic blocking agents are not allowed. 5.Patients must weigh at least 50 kg and must have a body mass index (BMI) within the range of 18 - 33 kg/m2. 6.Willing to abstain from activities that require focused attention 7.Willing and able to refrain from engaging in activities or work involving loud noise exposure 8.Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent 9.Willing to abstain from alcohol consumption Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria are not eligible 1.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations. 2.History of any significant drug allergy or a known hypersensitivity to any of the study drugs or to drugs of similar chemical classes, e.g. sulfonamide drugs 3.Patients diagnosed THI severity grade equal to 2 or 1 at Screening 4.Patients with diagnosis of intermittent or pulsatile tinnitus 5.Patients who have tinnitus as a concomitant symptom of a treatable otological disease 6.Patients with a history of frequent middle ear infections 7.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. 8.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) 9.Patients with Vestibular Schwannoma 10.Patients with a cochlear implant 11.A presence or past medical history, or family history (as far as known by the patient) of any of the following cardiovascular findings at Screening or Baseline 1: •2nd degree AV-block (type I or II) or 3rd degree AV-block and/or relevant arrhythmias •PR > 210 msec •QRS complex > 110 msec (except patients with known pre-existing right bundle branch block) •Prolonged QT-interval syndrome •QTcF > 450 msec (males) •QTcF > 470 msec (females) etc.........
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the multiple dose effects (including responder rates) of BGG492 after a 2-week treatment: i. on tinnitus loudness using a visual analogue scale (VAS) ii. on the clinical status of tinnitus (patients’ reaction to tinnitus) using the TBF-12 (engl.: Tinnitus Impairment Questionnaire) ;Secondary Objective: • To assess the effects of BGG492 both after single dose and a multiple dose 2-week treatment by the means of an audiological examination including audiometry, tinnitus matching, minimal masking level, and residual inhibition. • To assess the effects of a single dose of BGG492 on tinnitus loudness and annoyance using VAS (current loudness and current annoyance). • To assess the multiple dose effects of a 2-week treatment with BGG492 on tinnitus loudness (maximum loudness during last 24 hours) and tinnitus annoyance (current annoyance) using VAS. • To assess safety and tolerability of BGG492 in patients with chronic subjective tinnitus. • To determine the pharmacokinetic profile of BGG492 in patients with chronic subjective tinnitus and to explore the PK/PD relationship. ;Primary end point(s): • Tinnitus loudness (current) assessed by VAS (0-100 mm) after multiple dose treatment • Clinical status of tinnitus assessed by TBF-12 (0-24 points) after multiple dose treatment.;Timepoint(s) of evaluation of this end point: Day 15 (end of 1st treatment period) and Day 44 (end of 2nd treatment period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Audiological assessment • VAS (current loudness) and VAS (current annoyance) • VAS (maximum loudness during the last 24 hours • Safety and tolerability • Pharmacokinetics;Timepoint(s) of evaluation of this end point: • Audiological assessment at day 15 and day 44 (end of 1st/2nd treatment period) • VAS (current loudness) and VAS (current annoyance) at day 1 and day 30 (start of 1st/2nd treatment period), • VAS (maximum loudness during the last 24 hours at day 15 and day 44 (end of 1st/2nd treatment period), • Safety and tolerability- throughout the study • Pharmacokinetics day 1 and day 15, day 30 and day 44 (start/end of 1st/2nd treatment period) | — |
Countries
Germany, Netherlands, Switzerland
Contacts
Public ContactMedical Competence Center
Novartis Pharma GmbH
Outcome results
None listed