Proof of concept study assessing the efficacy of BGG492 in treating patients with chronic tinnitus.

• Conditions: indication tinnitus”. condition: patients with chronic subjective tinnitus.; MedDRA version: 14.1Level: PTClassification code 10043882Term: TinnitusSystem Organ Class: 10013993 - Ear and labyrinth disorders; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2010-022166-27-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-29
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

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 < 36 months) subjective tinnitus at Screening.
3.At Screening and Baseline 1, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the patient has rested for at least three (3) minutes.
4.When blood pressure and pulse are taken after at least 3 minutes standing, there should be no more than a 20 mm Hg drop in systolic or 10 mm Hg drop in diastolic blood pressure or increase in heart rate (>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

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.........

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified