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

Part of paid clinical trials in New Hyde Park, New York.

Sponsor
Northwell Health
Study ID
NCT03587701
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Autoimmune Inner Ear Disease
  • Meniere's Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Anakinra 100Mg/0.67Ml Inj Syringe (Period 1) — DRUG
    pre-filled syringes of anakinra 100mg/0.67mg will be provided and will be self-administered by patients daily during first 42 days of treatment (Period 1)
  • Placebo injection (Period 1) — DRUG
    pre-filled matching placebo injections will be provided and will be self-administered by patients daily during first 42 days of treatment (Period 1)
  • Anakinra 100Mg/0.67Ml Inj Syringe (Period 2) — DRUG
    pre-filled syringes of anakinra 100mg/0.67mg will be provided and will be self-administered by patients daily during next 42 days of treatment (Period 2)
  • Placebo injection (Period 2) — DRUG
    pre-filled matching placebo injections will be provided and will be self-administered by patients daily during next 42 days of treatment (Period 2)

Study Details

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.

Key Dates

Start date
Jan 3, 2019
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
57 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    This group will be randomized to receive intervention of 42 consecutive days of anakinra (100mg/0.67ml) in period 1 followed by an additional 42 consecutive days of anakinra (100mg/0.67ml) in period 2
  • Experimental: Group B
    This group will be randomized to receive intervention of 42 consecutive days of anakinra (100 mg/0.67ml) in period 1 followed by 42 consecutive days of placebo in period 2
  • Experimental: Group C
    This group will be randomized to receive intervention of placebo for 42 consecutive days in period 1 followed by 42 consecutive days of anakinra (100mg/0.67ml) in period 2

Primary Outcome Measure

Sustained improvement in hearing thresholds [ Time Frame: Hearing improvement from pre-treatment thresholds at day 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell Health, Hearing& Speech CenterNew Hyde ParkNew York11042
Andrea Vambutas, MD
[email protected]
718-470-7550
Ginny Mullooly, RN
[email protected]
718-470-7974

Find similar trials in New Hyde Park, NY

By research site
Northwell Health, Hearing& Speech Center· New Hyde Park, NY

Related Studies