Prednisone, Methotrexate, and Cyclophosphamide for Autoimmune Inner Ear Disease
Corticosteroids
+ Methotrexate
Ear Diseases+10
+ Hearing Disorders
+ Immune System Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
UCSD Medical Center
San Diego, United StatesUniv of Iowa Hosp and Clinic
Iowa City, United StatesJohns Hopkins Univ
Baltimore, United States