A Randomised, Double-Blind, Placebo-Controlled, Clinical Dose-Ranging Trial to Evaluate Efficacy and Safety of a NMDA antagonist for Oral Administration in Patients with Subjective Tinnitus

Conditions: Subjective Tinnitus
MedDRA version: 8.0Level: LLTClassification code 10042398

Registration Number: EUCTR2005-001592-36-AT

Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

Signed written informed consent

Patients with a clinical diagnosis of persistent, subjective, uni- or bilateral tinnitus present for at least 3 months but not more than 18 months. In case of bilateral tinnitus this criterion applies to both ears.

Outpatients (male or female) between 18 and 65 years of age (inclusively) at screening

TBF-12 total score > or equal to 9 at both screening and baseline

Physician’s global impression of tinnitus severity > or equal to 4 at both screening and baseline

Female patients must be at least 2 years post-menopausal or surgically sterile. Women of childbearing potential have to agree to use at least one effective method of contraception (e.g. oral contraceptive or condom) during the study

Negative pregnancy test for females of childbearing potential

Patients must be on a stable dose of other medications (if any) for a concurrent disease not mentioned as an exclusion criterion for at least 1 month

Are the trial subjects under 18?
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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Clinical diagnosis of intermittent or pulsatile tinnitus

History of Menière’s disease, epileptic seizures, brain surgery, acoustic neuroma, multiple sclerosis, serious head/ cervical trauma with residual deficits, anamnestic HIV infection or patients receiving antiepileptic medication

Hearing impairment related to disturbance of sound conduction (air conduction threshold more than 20 dB worse than in bone conduction in at least two tested frequencies)

Patients who have a clinically relevant neurological or psychiatric disorder (such as Parkinson’s disease, or dementia) or other severe or uncontrolled systemic diseases (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal) which might interfere with the trial

Concomitant tinnitus treatment during the last 28 days, e.g. biofeedback, maskers, noisers, acupuncture, hyperbaric oxygen therapy, low-power laser therapy, autogenic training, behavioural or psychotherapy

A sitting systolic blood pressure (left arm) greater than 160 mmHg or less than 90 mmHg or diastolic blood pressure greater than 100 mmHg or less than 50 mmHg at either screening or baseline

A sitting pulse rate of greater than 100 bpm or less than 50 bpm by palpitation.