EUCTR2008-001432-13-CZ进行中（未招募）不适用
An Open-Label, Long-Term Treatment Study to assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients with Subjective Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 840
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •- 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.
研究者
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