NCT00860808

Brief Summary

The purpose of the study is the evaluation of the therapeutic benefit of intratympanic AM 101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus following acute sensorineural hearing loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
248

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2009

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

Study Start

First participant enrolled

March 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

2.2 years

First QC Date

March 11, 2009

Last Update Submit

February 12, 2013

Conditions

Tinnitus

Keywords

tinnitus

Outcome Measures

Primary Outcomes (1)

  • Change in the minimum masking level from Baseline to Day 90

    Day 90

Secondary Outcomes (2)

  • Standard audiological evaluations

    D7, D30, D90

  • Questionaires evaluating the impact of tinnitus

    D7, D30, D90

Study Arms (3)

1 AM-101

EXPERIMENTAL

low dose

Drug: AM-101

2 AM-101

EXPERIMENTAL

high dose

Drug: AM-101

3 Placebo

PLACEBO COMPARATOR
Drug: AM-101

Interventions

AM-101DRUG

Triple intratympanic injection (one on each day 1, 2, and 3)

1 AM-1012 AM-1013 Placebo

Eligibility Criteria

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

You may qualify if:

  • Persistent tinnitus following acute acoustic trauma, sudden deafness, or acute otitis media with onset less than three months ago (i.e. acute tinnitus)
  • Tinnitus provoking incident of acute acoustic trauma, sudden deafness or acute otitis media is documented by audiogram and medical report and at onset resulted in an inner ear hearing loss of at least 15 dB in two adjacent frequencies
  • Minimum Masking Level (MML) of at least 5 dB SL
  • Age ≥ 18 years and ≤ 65 years
  • Negative pregnancy test for women of childbearing potential
  • Willing and able to attend the on-study visits
  • Must be able to read and understand the relevant study documents
  • Written informed consent before participation in the study

You may not qualify if:

  • Tinnitus that is not completely maskable
  • Fluctuating tinnitus
  • Intermittent tinnitus
  • Meniere's Disease
  • Acute or chronic otitis media or otitis externa
  • Any ongoing therapy known as potentially tinnitus-inducing (e.g. aminoglycosides, cisplatin, loop diuretics, high doses of aspirin, quinine etc.)
  • Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks, e.g. prednisolone, dexamethasone, pentoxifylline, betahistine, diazepam, carbamazepine, sodium valproate and antidepressants
  • Concomitant use of any other NMDA receptor antagonist (e.g. memantine, dextromethorphan, ifenprodil)
  • Any ongoing or planned concomitant medication for the treatment of tinnitus until 90 days after study drug application
  • History or presence of drug abuse or alcoholism
  • Any clinically relevant respiratory, cardiovascular, neurological (except vertigo), or psychiatric disorder
  • Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
  • Women who are breast-feeding, pregnant or who plan a pregnancy during the trial
  • Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner
  • Concurrent participation in another clinical trial with an investigational drug or participation in another clinical trial with an investigational drug within 30 days prior to study entry
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bundeswehrkrankenhaus Ulm

Ulm, 89081, Germany

Location

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 Officials

  • Heinz Maier, MD

    Bundeswehrkrankenhaus Ulm

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2011

Study Completion

August 1, 2011

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

DE(1)