Long-term safety, tolerability and efficacy of Neramexane in Patients with subjective Tinnitus. MedDRA version: 9.1 Level: LLT Classification code 10042398 Term: Subjective tinnitus
Conditions
Interventions
Product Name: Neramexane mesylate IR film-coated tablet 12.5 mg
Product Code: Neramexane mesylate IR film-coated tablet 12.5 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Neramexane
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of the study is to evaluate the long-term safety and tolerability of daily doses of 50 or 75 mg (depending on fixed dose in the respective lead-in study) neramexane mesylate in the treatment of subjective tinnitus. The study will also investigate the durability of treatment effects (long-term efficacy);Secondary Objective: no secondary objectives defined;Primary end point(s): The current study is designed to investigate the long-term safety of neramexane in patients who completed one of the clinical studies MRZ 92579/TI/3001, 3002 or 3003. In addition the longterm effect on the efficacy variables TBF-12, Tinnitus Rating Scale and SF-36 will be investigated. No confirmatory statistical hypothesis testing is aimed at. The study will be analyzed purely descriptive. Besides the baseline measurements from the respective lead-in study, only safety and efficacy data from the current OLLTT study will be included. Any pooling of data from lead-in and OLLTT will be subject of the integrated safety summary. | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed