An Open-Label, Long-Term Treatment Study to assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients with Subjective Tinnitus

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 840

Inclusion Criteria

1) Signed written informed consent obtained from the patient
2) Male or female patients who have successfully completed one of the double-blind studies MRZ 92579 TI 3001, MRZ 92579 TI 3002, or MRZ 92579 TI 3003 (attended all visits - with questionnaires and scales performed - of the respective lead-in study without premature termination) and who have been deemed eligible in the judgement of the Investigator, based on inclusion/exclusion criteria
3) Patient fulfilled, at entry into the double-blind study, the diagnostic criteria for first onset, persistent, uni- or bilateral subjective tinnitus
4) For females of childbearing potential (last menses less than one year prior to enrolment): negative pregnancy test at screening and at baseline (i.e. prior to entry in the double-blind treatment phase); not breast-feeding; either surgically sterile or agreement to use a medically accepted, highly effective contraception during the
entire duration of the study A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
5) Patient must be willing and able to comply with the protocol and study procedures
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

1) Clinical diagnosis of intermittent or pulsatile tinnitus
2) Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Menière’s disease, otosclerosis, etc)
3) Patients with evidence of clinically relevant and active
- Pulmonary
- Cardiovascular
- Renal
- Hepatic
- Gastrointestinal
- Neurological (e.g. epileptic seizures, multiple sclerosis, serious head/cervical trauma with residual deficits)
- Psychiatric (e.g. dementia, schizophrenia, current major depressive episode)
- Infectious (e.g. HIV infection/AIDS, tuberculosis)
- Endocrine
disorder of concern or other severe or uncontrolled systemic diseases which might interfere with the trial (patients with controlled diabetes who are normoglycemic under treatment may be included).
4) A systolic blood pressure (while seated) greater than 180 mmHg or less than 90 mmHg or diastolic blood pressure (while seated) greater than 105 mmHg or less than 45 mmHg
5) Patients with an oncology diagnosis (hematology or solid tumor) who are undergoing treatment, who have completed treatment within the last six months, and/or who still have evidence of active disease. (Patients with localized, benign dermatologic lesions may be included)
6) Former treatment with memantine, rimantadine, amantadine
7) Documented history of hypersensitivity or intolerance to NMDA antagonists
8) Known hypersensitivity to the study drug or one of the ingredients of the formulation
9) Current absence from work due to tinnitus or application for a pension/retirement pay or granted pension/retirement because of tinnitus
10) Concomitant drugs and supplements intended for tinnitus treatment as well as non-pharmacological tinnitus treatments, e.g. biofeedback, maskers, noisers, acupuncture, hyperbaric oxygen therapy, low-power laser therapy, autogenic training, behavioural or psychotherapy .
11) Patients who are taking any non-authorised concomitant medication as defined in Appendix 4 of the study protocol
12) Patients who plan to undergo elective surgery under local or general anaesthesia during the study
13) Known or suspected alcoholism or drug abuse within the last three years
14) Patients who have participated in a clinicial study other than the double-blind studies MRZ 92579/TI/3001, MRZ 92579/TI/3002 or MRZ 92579/TI/3003 in the last 30 days or (or 5 half-lifes of the drug, whichever is longer)
15) Pregnant or breastfeeding women
16) Employees or direct relatives of an employee of the CRO, the investigational site or Merz Pharmaceuticals
17) Patients who are lawfully kept in an institution or are imprisoned
18) Occurrence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579/TI/3001, MRZ 92579/TI/3002, or MRZ 92579/TI/3003) that, in the opinion of the Investigator, should exclude the patient from participating in the open-label long-term treatment study
19) Relevant non-compliance issue(s) in the previous protocol or a history of chronic non-compliance with drug regimens
20) Evidence or suspicion that the subject is not willing or unable to understand the information that is given to him/her as part of the informed consent, in particular regarding the risks and discomfort to which he/she would agree to be exposed.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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