Trial record 6 of 6 for:    Open Studies | "Meniere Disease"

The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by XOMA (US) LLC
Sponsor:
Collaborators:
Feinstein Institute for Medical Research
Information provided by (Responsible Party):
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT01950312
First received: September 20, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy in patients with steroid resistant Autoimmune Inner Ear Disease.


Condition Intervention Phase
Autoimmune Inner Ear Disease
Drug: gevokizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of the Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

Resource links provided by NLM:


Further study details as provided by XOMA (US) LLC:

Primary Outcome Measures:
  • Improved hearing threshold, as defined by an improvement in either the PTA (Pure Tone Average) of >=5 dB (Decibel), or 12% in the WRS (Word Recognition Score) [ Time Frame: Day 28 to Day 84 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gevokizumab
Solution for subcutaneous injection
Drug: gevokizumab

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Autoimmune Inner Ear Disease with active deterioration in at least one ear
  • Failure to respond to a trial of high-dose corticosteroid therapy
  • Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

  • Evidence of retrocochlear pathology (vestibular schwannoma) or inner ear malformation (Mondini Malformation or Enlarged Vestibular Aqueduct)
  • History of active or chronic infections
  • Currently receiving, or having received treatment for a malignancy in the past three years
  • Hearing loss that coincides with significant, disabling episodes of vertigo
  • History of allergic or anaphylactic reactions to monoclonal antibodies
  • Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950312

Locations
United States, New York
Long Island Jewish Medical Center, Hearing & Speech Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Andrea Vambutas, MD    718-470-7550      
Contact: Ginny Mullooly    718-470-7974      
Principal Investigator: Andrea Vambutas, MD         
Sponsors and Collaborators
XOMA (US) LLC
Feinstein Institute for Medical Research
  More Information

No publications provided

Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT01950312     History of Changes
Other Study ID Numbers: X052180, R33DC011827
Study First Received: September 20, 2013
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by XOMA (US) LLC:
Autoimmune Inner Ear Disease
Inner Ear Disease
Meniere's Disease
Sudden Sensorineural Hearing Loss

Additional relevant MeSH terms:
Ear Diseases
Labyrinth Diseases
Labyrinthitis
Otorhinolaryngologic Diseases
Otitis

ClinicalTrials.gov processed this record on September 18, 2014