Suspended

Prednisone, Methotrexate, and Cyclophosphamide for Autoimmune Inner Ear Disease

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Corticosteroids

+ Methotrexate

Drug
Who is being recruted

Ear Diseases+10

+ Hearing Disorders

+ Immune System Diseases

From 18 to 70 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 1998
See protocol details

Summary

Principal SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)
Last updated: April 24, 2006
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1998

Actual date on which the first participant was enrolled.

This study focuses on a condition called Autoimmune Inner Ear Disease (AIED), which causes rapid hearing loss in both ears. The goal is to test if certain drugs - prednisone, methotrexate, and cyclophosphamide - can effectively treat this condition. AIED is believed to be triggered by the body's own immune system attacking the inner ear, and these drugs are used to control this process due to their strong anti-inflammatory properties. The study is important as it aims to find a treatment for AIED, potentially improving the quality of life for those affected by this condition. The study is conducted in an outpatient setting and is in its Phase III. Participants are divided into four groups, each testing a different combination of the drugs. The study lasts for 18 months and requires a minimum of 11 visits from each participant. During this time, the effectiveness of the drugs in treating AIED is evaluated. The study does not mention specific potential risks, but the use of strong anti-inflammatory drugs is typically monitored closely to ensure patient safety.

NCT00000361
Principal SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)
Last updated: April 24, 2006
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ear DiseasesHearing DisordersImmune System DiseasesNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsHearing LossAutoimmune DiseasesHearing Loss, SensorineuralLabyrinth Diseases

Criteria

4 inclusion criteria required to participate
Are able to speak and understand English or Spanish

Are in good general health

Are sterile or use contraception (if a woman of child-bearing age)

Have sensorineural (nerve/inner ear) hearing loss of at least 30 dB in each ear, which has rapidly progressed

7 exclusion criteria prevent from participating
Are breast-feeding or pregnant

Have any significant heart, lung, digestive, blood, or neurologic disorders

Have any type of middle ear disorder

Have had a positive test for HIV, hepatitis C or B

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

House Ear Institute

Los Angeles, United StatesOpen House Ear Institute in Google Maps

UCSD Medical Center

San Diego, United States

Univ of Iowa Hosp and Clinic

Iowa City, United States

Johns Hopkins Univ

Baltimore, United States
Suspended9 Study Centers