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 TinnitusMedDRA version: 8.1Level: LLTClassification code 10042398Term: Subjective tinnitus
- Registration Number
- EUCTR2005-001592-36-DE
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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? 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) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to compare the efficacy, tolerability and safety of neramexane in three different dosages (25, 50 or 75 mg/d) with placebo in patients with subjective tinnitus of at least moderate severity after a 16-week double-blind treatment period.;Secondary Objective: ;Primary end point(s): Primary efficacy parameter:<br>Change from baseline in the TBF-12 (Tinnitus Impairment Questionnaire-12, Tinnitus-Beeinträchtigungs-Fragebogen”-12) total score at the endpoint visit (week 16)
- Secondary Outcome Measures
Name Time Method