Anakinra for Meniere's Disease

Overseen By Ginny Mullooly, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwell Health

Must be taking: Corticosteroids

Must not be taking: Methotrexate, TNF-antagonists

Disqualifiers: Immunodeficiency, Chronic infections, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

57 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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.

Research Team

Andrea Vambutas, MD

Principal Investigator

Northwell Health

Eligibility 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)

Exclusion Criteria

Pregnant or lactating females

Evidence of retrocochlear pathology or inner ear malformation based on imaging

History of active narcotic abuse

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

Treatment Details

Interventions

• Anakinra

Trial Overview 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.

Participant Groups

Group I: Group C Experimental Treatment 2 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 B Experimental Treatment 2 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 A Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Swedish Orphan Biovitrum

Industry Sponsor

Trials

103

Recruited

13,300+

Dr. Guido Oelkers

Swedish Orphan Biovitrum

Chief Executive Officer since 2017

PhD in Economics

Dr. Lydia Abad-Franch

Swedish Orphan Biovitrum

Chief Medical Officer since 2023

MD, MBA

Findings from Research

Meniett therapy has been shown to effectively reduce the frequency of vertigo attacks in patients with Ménière's disease, based on a meta-analysis of 14 studies involving 345 patients.

The therapy may also help alleviate functional deficits associated with the disease, although its impact on hearing remains unclear, and the benefits may last for about 18 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meniett Therapy for Ménière's Disease: An Updated Meta-analysis. Zhang, SL., Leng, Y., Liu, B., et al.[2018]

In a 2-year follow-up study of 61 participants with unilateral Ménière's disease, 67% experienced significant improvement in vertigo frequency using the Meniett device, indicating its efficacy as a treatment option.

The majority of participants who achieved remission (80%) maintained their improvement long-term, suggesting that the Meniett device is a safe and effective alternative for those unresponsive to traditional medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meniett clinical trial: long-term follow-up. Gates, GA., Verrall, A., Green, JD., et al.[2015]

In a study of 33 patients with unilateral Ménière's disease, 90.9% responded to questionnaires, showing that the Meniett® device significantly alleviated symptoms, with 63.3% reporting reduced vertigo and tinnitus.

The Meniett® device is a well-tolerated and minimally invasive treatment option for Ménière's disease, providing a beneficial alternative before considering more invasive and potentially harmful therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial UK experience of patient satisfaction with the Meniett® device for Ménière's disease treatment. Buchanan, MA., Rai, A., Prinsley, PR.[2019]

The Meniett device is a safe and minimally invasive treatment that effectively reduces vestibular symptoms in patients with delayed endolymphatic hydrops (DEH) and Meniere's disease (MD), with 57% of MD patients and 100% of DEH patients remaining free from vertigo spells after treatment.

In a study involving 33 patients who had not responded to other medical treatments, 74% maintained stable hearing levels, indicating that the Meniett device does not adversely affect hearing while providing symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Shojaku, H., Watanabe, Y., Mineta, H., et al.[2011]

Intratympanic steroid treatment may slightly reduce the frequency of vertiginous attacks in patients with Menière's disease, but the evidence is weak and based on very low-quality studies.

No serious adverse events were reported, indicating that the treatment is likely safe; however, further research is necessary to determine its overall efficacy and safety in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intratympanic Steroid for Menière's Disease: A Systematic Review. Devantier, L., Djurhuus, BD., Hougaard, DD., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Meniett Therapy for Ménière's Disease: An Updated Meta-analysis. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Meniett clinical trial: long-term follow-up. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Initial UK experience of patient satisfaction with the Meniett® device for Ménière's disease treatment. [2019]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Intratympanic Steroid for Menière's Disease: A Systematic Review. [2020]