NCT02040207

Brief Summary

The purpose of this research study is to test the safety and local tolerance of repeated treatment with AM-101.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
487

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

2.5 years

First QC Date

January 14, 2014

Last Update Submit

September 13, 2023

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

  • Hearing threshold

    Occurrence of deterioration in hearing threshold in the treated ear(s)

    Up to Day 203

Secondary Outcomes (2)

  • Hearing threshold

    Up to Day 252

  • Adverse events and serious adverse events

    Up to Day 252

Study Arms (1)

AM-101 injection

EXPERIMENTAL

AM-101 gel for intratympanic injection

Drug: AM-101

Interventions

AM-101DRUG

AM-101 gel for intratympanic injection

AM-101 injection

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completion of TACTT3 study;
  • Negative pregnancy test (woman of childbearing potential);
  • Willing and able to attend the study visits.

You may not qualify if:

  • Adverse event leading to treatment discontinuation in TACTT3;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational site

Munich, Germany

Location

Related Links

MeSH Terms

Conditions

Tinnitus

Interventions

PDCD5 protein, rat

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 20, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

DE(1)