Phase 3
Completed N=257
AM-101 in the Treatment of Post-Acute Tinnitus 1
Source: ClinicalTrials.gov NCT01934010 ↗Enrolled (actual)
257
Serious AEs
1.6%
Results posted
Mar 2018
Primary outcomePrimary: Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction) — 10; 2; 2 Number subject affected — p=0.128
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this research study is to test the safety and local tolerance of repeated treatment cycles of AM-101.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction) |
10; 2; 2 | 0.128 |
| PRIMARY Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction) |
1; 0 | 0.4403 |
| PRIMARY Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction) |
2 | — |
| SECONDARY Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction) |
10; 3; 0 | 0.2401 |
| SECONDARY Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction) |
0; 1 | 1.0 |
| SECONDARY Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction) |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Completion of TACTT2 study;
- Negative pregnancy test (woman of childbearing potential);
- Willing and able to attend the study visits during at least one treatment cycle.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Adverse event leading to treatment discontinuation in TACTT2;
- Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;
- Ongoing drug-based therapy for otitis media or otitis externa;
- Drug-based therapy known as potentially tinnitus-inducing;
- Other treatment of tinnitus;
- Drug abuse or alcoholism;
- Subjects with psychiatric diseases requiring drug treatment;
- Use of antidepressant or anti-anxiety medication;
- Any clinically relevant disorder or abnormality in physical examination;
- Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
- Women of childbearing potential who are unwilling or unable to practice contraception.
Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01934010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.