Anakinra for Meniere's Disease
Recruiting in Palo Alto (17 mi)
Overseen byAndrea Vambutas, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Northwell Health
Must be taking: Corticosteroids
Must not be taking: Methotrexate, TNF-antagonists
Disqualifiers: Immunodeficiency, Chronic infections, Cancer, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be on methotrexate, TNF-antagonist therapy, or any other immunosuppressive therapy. No new diuretics can be started or doses increased 28 days before joining the trial.
How is the drug Anakinra different from other treatments for Meniere's disease?
Anakinra is unique because it is an anti-inflammatory drug that blocks interleukin-1 (a protein that can cause inflammation), which is different from other treatments like the Meniett device or intratympanic steroids that focus on pressure changes or direct steroid application to the ear.
12345Eligibility Criteria
This trial is for adults with severe hearing loss due to Meniere's Disease or Autoimmune Inner Ear Disease who haven't improved with steroids. Participants must have stable or worsening hearing, not be on certain immunosuppressives, and can't start new diuretics before the trial. They should understand English, use effective birth control, and not have specific ear conditions or infections.Inclusion Criteria
Patients must be fluent in English
Females of childbearing potential must be practicing a method of birth control
Patients may have other autoimmune disease(s)
+7 more
Exclusion Criteria
Pregnant or lactating females
Evidence of retrocochlear pathology or inner ear malformation based on imaging
History of active narcotic abuse
+18 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Period 1
Participants receive either anakinra or placebo for 42 consecutive days
6 weeks
Daily self-administration
Treatment Period 2
Participants continue with either anakinra or switch to placebo for an additional 42 consecutive days
6 weeks
Daily self-administration
Observation
A 264-day observation period where hearing declines may be re-treated with anakinra
264 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests Anakinra (a drug) against a placebo in patients resistant to corticosteroids over two periods of 42 days each. Patients are randomly chosen to receive either Anakinra or placebo in a 2:1 ratio. After these periods, there's an observation phase where declines in hearing may be treated again with Anakinra.
3Treatment groups
Experimental Treatment
Group I: Group CExperimental Treatment2 Interventions
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
Group II: Group BExperimental Treatment2 Interventions
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
Group III: Group AExperimental Treatment2 Interventions
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
Anakinra is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Kineret for:
- Rheumatoid arthritis
- Cryopyrin-associated periodic syndromes
- Deficiency of interleukin-1 receptor antagonist
- COVID-19
🇺🇸 Approved in United States as Kineret for:
- Rheumatoid arthritis
- Deficiency of interleukin-1 receptor antagonist
- Neonatal-onset multisystem inflammatory disease (NOMID)
- COVID-19
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwell Health, Hearing& Speech CenterNew Hyde Park, NY
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Who Is Running the Clinical Trial?
Northwell HealthLead Sponsor
Swedish Orphan BiovitrumIndustry Sponsor
References
Meniett Therapy for Ménière's Disease: An Updated Meta-analysis. [2018]To re-evaluate the efficacy of Meniett therapy for the treatment of Ménière's disease (MD).
Meniett clinical trial: long-term follow-up. [2015]To delineate 2-year efficacy of Meniett device therapy in people with classic, unilateral, Ménière's disease unresponsive to traditional medical treatment.
Initial UK experience of patient satisfaction with the Meniett® device for Ménière's disease treatment. [2019]To evaluate patient satisfaction and symptom improvement following treatment of Ménière's disease with the Meniett® device.
Long-term effects of the Meniett device in Japanese patients with Meniere's disease and delayed endolymphatic hydrops reported by the Middle Ear Pressure Treatment Research Group of Japan. [2011]The Meniett device is a minimally invasive and safe treatment that may be used to provide longer-term reduction of vestibular symptoms in patients with delayed endolymphatic hydrops (DEH) as well as those with Meniere's disease (MD).
Intratympanic Steroid for Menière's Disease: A Systematic Review. [2020]To investigate the beneficial effects and safety of intratympanic steroid installation compared with placebo in patients with Menière's disease.