Hearing Loss, SensorineuralPhase 3NCT00000361
Autoimmunity in Inner Ear Disease
A Phase 3 study testing Corticosteroids and Methotrexate in people with Hearing Loss, Sensorineural, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 9 sites in United States.
Trial summary
The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing loss in both ears. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Corticosteroids and Methotrexate
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- Mar 1998to Nov 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have sensorineural (nerve/inner ear) hearing loss of at least 30 dB in each ear, which has rapidly progressed.
- Are in good general health.
- Are sterile or use contraception (if a woman of child-bearing age).
- Are able to speak and understand English or Spanish.
Who cannot join
- Have had any previous reaction to prednisone, or history of psychiatric reaction to corticosteroids.
- Have used corticosteroids for more than 30 days within the past 90 days. Patients who have been off corticosteroids for at least 30 days may be eligible.
- Have any significant heart, lung, digestive, blood, or neurologic disorders.
- Have tuberculosis (TB), brittle or unstable insulin-dependent diabetes mellitus, active malignancy or prior chemotherapy, pancreatitis, active peptic ulcer disease, kidney failure, history of shingles, or known (other) autoimmune disease.
- Have had a positive test for HIV, hepatitis C or B.
- Have any type of middle ear disorder.
- Are breast-feeding or pregnant.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Univ of Michigan
Ann Arbor, Michigan, 48109-0005
Johns Hopkins Univ
Baltimore, Maryland, 21287-0008
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-5245
University of Texas, Southwestern Medical Center at Dallas
Dallas, Texas
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242-1078
House Ear Institute
Los Angeles, California, 90057
New York University
New York, New York
UCSD Medical Center
San Diego, California, 92103-8895
About this study
The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III, outpatient study. All study participants will be assigned to one of four different groups testing the experimental use of drugs. The study is scheduled to run for 18 months, with a minimum of 11 visits per participant.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Corticosteroids, Methotrexate
- Keywords
- Autoimmune Diseases, Cyclophosphamide, Hearing, Labyrinth Diseases, Methotrexate, Prednisone
- Medical subject headings
- Hearing Loss, Sensorineural, Autoimmune Diseases, Labyrinth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidsDrug
MethotrexateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startMar 1998
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Dr. Jeffrey Harris, Study chairDr. Patrick Brookhouser, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000361
- Sponsor's protocol ID
- NIDCD-1158
- Other IDs
- U01DC003209
- Status last verified
- Apr 2006
- First submitted
- 2 Nov 1999
- Last updated
- 24 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoimmunity in Inner Ear Disease
- ClinicalTrials.gov ID
- NCT00000361
- Acronym / sponsor ID
- NIDCD-1158
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Autoimmune Diseases, Cyclophosphamide, Hearing, Labyrinth Diseases, Methotrexate, Prednisone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- Mar 1998
- Study completion
- Nov 2002
- First posted
- 3 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III, outpatient study. All study participants will be assigned to one of four different groups testing the experimental use of drugs. The study is scheduled to run for 18 months, with a minimum of 11 visits per participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have sensorineural (nerve/inner ear) hearing loss of at least 30 dB in each ear, which has rapidly progressed.
- Are in good general health.
- Are sterile or use contraception (if a woman of child-bearing age).
- Are able to speak and understand English or Spanish.
Key exclusion criteria (7 listed)
- Have had any previous reaction to prednisone, or history of psychiatric reaction to corticosteroids.
- Have used corticosteroids for more than 30 days within the past 90 days. Patients who have been off corticosteroids for at least 30 days may be eligible.
- Have any significant heart, lung, digestive, blood, or neurologic disorders.
- Have tuberculosis (TB), brittle or unstable insulin-dependent diabetes mellitus, active malignancy or prior chemotherapy, pancreatitis, active peptic ulcer disease, kidney failure, history of shingles, or known (other) autoimmune disease.
- Have had a positive test for HIV, hepatitis C or B.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroids | Drug | – |
| Methotrexate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Jeffrey Harris study chair
Dr. Patrick Brookhouser principal investigator
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Corticosteroids and Methotrexate in people with Hearing Loss, Sensorineural, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2006.