Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02828033|
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Neurosensory Hearing Loss (ANSHL)||Drug: Rilonacept||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial of Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
A loading dose of 320 mg the first dose then be a once-weekly injection of 160 mg for 24 weeks
All patients will receive rilonacept with an initial loading dose of 320 mg delivered as two, 2-mL, subcutaneous injections of 160 mg each given on the same day at two different sites. The initial dose will be administered at the study site by study personnel. Dosing will then be a once-weekly injection of 160 mg administered as a single, 2-mL, subcutaneous injection by the patient at home. Patients will be dosed for 24 weeks.
- Improvement in hearing in comparison to baseline values [ Time Frame: 24 weeks ]
- An improvement in pure tone average (500 to 3000 Hz) by 10 dB in at least one ear or
- An improvement of word identification score of at least 12 percent; both relative to baseline values
- Pt reported evaluation of auditory acuity [ Time Frame: 24 weeks ]Pt reported evaluation of auditory acuity as measured on a 0-100 Visual Analog Scale (VAS). Patients with a 25% improvement in VAS will be considered responders.
- Vertigo evaluation [ Time Frame: 24 weeks ]Vertigo will be evaluated using the validated OTA Dizziness Handicap Inventory (DHI). A change in category is considered clinically significant.
- Tinnitus evaluation [ Time Frame: 24 weeks ]Tinnitus will be evaluated using the validated OTA Tinnitus Handicap Inventory (THI). A change of 6 points on this scale is considered clinically meaningful.
- Quality of Life assessment [ Time Frame: 24 weeks ]Validated auditory quality of life questionnaire- Response is defined as a 5% or greater improvement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828033
|Contact: Stanley B Cohen, MDfirstname.lastname@example.org|
|Contact: Cindy Cabreraemail@example.com|
|United States, Texas|
|Metroplex Clinical Research Center||Recruiting|
|Dallas, Texas, United States, 75231|
|Contact: Cindy Cabrera 214-879-6737 firstname.lastname@example.org|
|Contact: Tonja Hill 214-879-6737 email@example.com|
|Principal Investigator:||Stanley B Cohen, MD||Metroplex Clinical Research Center|