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Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026v11
  2. Re-verified, no change to tracked fieldsv10
  3. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v9
  4. Eligibility criteria shortened, about 1 word Study title expanded, about 4 wordsv8 Show 1 more changeShow less
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary and study completion dates: Sep 1, 2022 to Dec 31, 2024 Eligibility criteria shortened, about 14 words · Study description expanded, about 27 wordsv7 Show 2 more changesShow less
    • Eligibility criteria shortened, about 14 words
    • Study description expanded, about 27 words

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Eligibility criteria expanded, about 1 wordv6 See this version in full on ClinicalTrials.gov ↗
  2. Eligibility criteria expanded, about 19 wordsv5 See this version in full on ClinicalTrials.gov ↗
  3. Eligibility criteria expanded, about 89 words Study description shortened, about 39 wordsv4 Show 1 more changeShow less
    • Study description shortened, about 39 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date changed from estimate of Sep 1, 2018 to Jan 3, 2019v3
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A Phase II randomized, placebo controlled study design of anakinra (Kineret) in corticosteroid-resistant or intolerant Meniere's disease (CR-MD)and corticosteroid-resistant or intolerant autoimmune inner ear disease (CR-AIED) patients. Patients will be randomized by a 2:1 allocation to anakinra or placebo for 42 continuous days. After day 42, a second placebo-controlled period will begin for an additional 42 days. This will be followed by a 264 day observation period, during which, hearing declines may be re-treated with anakinra after 30 days following the initial drug.
Trial Details
NCT Number NCT03587701
Lead Sponsor Northwell Health
Collaborators: Swedish Orphan Biovitrum
Conditions Autoimmune Inner Ear Disease, Meniere's Disease
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov