EUCTR2013-001527-39-ES进行中（未招募）1 期
AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) ? an open-label extension to the TACTT3 study - AMPACT2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •A subject will be eligible for this study if all of the following criteria apply:
- •1. Attendance of the final visit FUV3 of study AM-101-CL-12-02
- •TV1 of AMPACT2 should preferably be conducted within 48 hours of
- •FUV3 of TACTT3, but no later than 14 days thereafter.
- •2. Negative urine pregnancy test for women of childbearing potential;
- •Women are not considered to be of childbearing potential if they meet 1
- •of the following criteria:
- •a. They have had a hysterectomy or tubal ligation at minimum 1 cycle
- •prior to signing the ICF or
- •b. They are post menopausal, defined as ?1 year since their last
- •menstrual period for women ?55 years of age or ?1 year since their
- •last menstrual period and have a follicle stimulating hormone (FSH)
- •level in menopausal range for women <55 years of age2;
- •3. Willing and able to attend the study visits during at least one treatment
- •4. Able to read and understand study documents, to complete the relevant
- •questionnaires and rating scales and follow Investigator instructions;
- •5. Able to understand and follow study personnel instructions during
- •audiologic measurements;
- •6. Willing and able to use adequate hearing protection, respectively to
- •refrain from engaging in activities or work involving loud noise exposure
- •where sufficient hearing protection is not possible or ensured;
- •7. Willing and able to protect ear canal and middle ear from water exposure
- •as long as tympanic membrane is not fully closed after IMP
- •administration;
- •8. Signed IRB/IEC approved Informed Consent Form (ICF).
- •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 540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •A subject will not be eligible for this study if any of the following criteria
- •1. Study drug related or procedure related adverse event leading to
- •treatment discontinuation in study AM-101-CL-12-02 (TACTT3);
- •2. Suspected or diagnosed Meniere?s Disease, endolymphatic hydrops,
- •acoustic neuroma or history of fluctuating hearing loss;
- •3. Ongoing purulent acute or chronic otitis media or otitis externa;
- •4. Abnormality of the tympanic membrane in the affected ear(s) that would
- •preclude i.t. injection;
- •5. Subjects with current hearing loss in the affected ear(s) of 75 dB or more
- •in one or more test frequencies (250 Hz, 500 Hz, 1 kHz, 2 kHz, 3 kHz, 4
- •kHz, 6 kHz, 8 kHz);
- •6. Any ongoing drug-based therapy for otitis media or otitis externa;
- •7. Any drug-based therapy known as potentially tinnitus-inducing (e.g.
- •aminoglycosides, cisplatin, loop diuretics, high doses of aspirin [>2 g
- •/day] or quinine) in the past 2 weeks prior to enrolment into the openlabel
- •study (TV1, D0), or that is ongoing or planned for the study
- •8. Use of any other NMDA receptor antagonist (e.g. memantine,
- •dextromethorphan) that is planned for the study duration;
- •9. Any planned pharmacological or non-pharmacological treatment of
- •tinnitus for the study duration;
- •10. History within the past two years or presence of drug abuse or
- •alcoholism;
- •11. Subjects with diagnosed anxiety disorders, depression, bipolar disorder,
- •schizophrenia or other significant psychiatric diseases requiring current
- •drug treatment or subjects who required treatment in the previous
- •TACTT3 study prior to enrolment into the open-label study (TV1, D0)
- •for these diseases;
- •12. Use of any antidepressant or anti-anxiety medication in the past 2 weeks
- •prior to enrolment into the open-label study (TV1, D0), or that is
- •ongoing, or that is planned for the study duration unless the medication
- •was taken in a low dose and permanently during the previous TACTT3
- •study prior to enrolment into the open-label study (TV1, D0), not for the
- •treatment of tinnitus, and if the treatment will be maintained throughout
- •the duration of the study;
- •13. Any clinically relevant respiratory, cardiovascular, neurological disorder
- •(except vertigo), as determined by the Investigator;
- •14. Any clinically relevant abnormalities in physical examination on Day 0
- •(TV1, D0);
- •15. Women who are breast-feeding, pregnant or who are planning to become
- •pregnant during the study;
- •16. Women of childbearing potential who are unwilling or unable to use an
- •effective method of avoiding pregnancy from enrolment into the openlabel
- •study (TV1, D0) until the end of the study (FUV3, FUV6 or FUV9).
- •Effective methods of avoiding pregnancy are contraceptive methods with
- •a Pearl index of less than 1 used consistently and correctly (including
- •implantable contraceptives, injectable contraceptives, oral contraceptives,
- •transdermal contraceptives, intrauterine devices, diaphragm with
- •spermicide, male or female condoms with spermicide, or cervical cap, or
- •a sterile sexual partner);
- •17. Involvement or planned involvement in legal action related to the present
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研究者
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