EUCTR2008-000639-16-FR进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients with Subjective Tinnitus
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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) Patients with a clinical diagnosis of first onset, persistent (i.e. tinnitus should never be absent for > 24 hours in a row), subjective, uni- or bilateral tinnitus present for at least 3 months but not more than 12 months. In case of bilateral tinnitus this criterion applies to both ears.
- •3) Outpatients (male or female) between 18 and 75 years of age (inclusively) at screening
- •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) TBF-12 total score = 9
- •6) HADS depression subscore = 10 and HADS anxiety subscore = 10
- •7) Physical examination and laboratory evaluations from the screening visit must be normal, or abnormal findings must be judged either not clinically relevant” or clinically relevant but of no concern” by the Investigator
- •8) 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) Hearing impairment related to disturbance of sound conduction (air conduction threshold more than 20 decibel (dB) worse than in bone conduction in at least two tested frequencies)
- •4) Patients with evidence of clinically relevant and active
- •-Pulmonary
- •-Cardiovascular (e.g. sinus bradycardia < 41 bpm, sinus pauses, ventricular fibrillation, non-sustained sinus bradycardia, 2:1 AV block, complete heart block, first degree AV block if > 300 msec, AV block Mobitz II, prolonged QTc if > 500 msec, WPW syndrome, ST elevation, abnormal U wave, cardiac insufficiency NYHA III-IV or a history of myocardial ischaemia/infarction within the last 6 months)
- •-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).
- •5) 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
- •6) 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)
- •7) Former treatment with memantine, neramexane, rimantadine, amantadine
- •8) Documented history of hypersensitivity or intolerance to NMDA antagonists
- •9) Known hypersensitivity to the study drug or one of the ingredients of the formulation
- •10) Current absence from work due to tinnitus or application for a pension/retirement pay or granted pension/retirement because of tinnitus
- •11) 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 during the last 28 days,
- •12) Patients who are taking any non-authorised concomitant medication as defined in Appendix 6 of the study protocol
- •13) Patients who plan to undergo elective surgery under local or general anaesthesia during the trial
- •14) Known or suspected alcoholism or drug abuse within the last three years
- •15) Patients who have participated in an investigational drug study or who have received treatment with an investigational drug within 30 days (or 5 half-lifes, whichever is longer) of screening
- •16) Pregnant or breastfeeding women
- •17) Employees or direct relatives of an employee of the CRO, the investigational site or Merz Pharmaceuticals
- •18) Patients who are lawfully kept in an institution or are imprisoned
- •19) Previous participation in this clinical study
- •20) Evidence or suspicion that the patient might not comply with the study directives and/or that he/she is not reliable or trustworthy.
- •21) Evidence or suspicion that the patient is not willing or unable to understand the information that is given to him/her as pa
研究者
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