Study to observe long-term safety of AM-101 in patients with tinnitus

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

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
(TACTT3);
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
cycle;
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

Exclusion Criteria

A subject will not be eligible for this study if any of the following criteria
apply:
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
duration;
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
peripheral tinnitus during the course of the study;
18. Concurrent participation in another clinical study.