Meniere DiseasePhase 3PREDMENNCT05851508
The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease
A Phase 3 study testing Methylprednisolon in people with Meniere Disease, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Ménière's disease is an inner ear disorder in which patients suffer from attacks of vertigo, tinnitus and hearing loss. To date, it is unclear what the best treatment for this condition is. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniere Disease
- What is being tested?
- Methylprednisolon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2023to 1 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral, definite MD according to the diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disorders published in 2015 [7] (see Appendix 1):
- Definite MD Two or more spontaneous episodes of vertigo, each lasting 20 minutes to 12 hours, AND Audiometrically documented low- to medium-frequency sensorineural hearing loss in one ear, defining the affected ear on at least one occasion before, during or after one of the episodes of vertigo, AND Fluctuating aural symptoms (hearing, tinnitus, or fullness) in affected ear (not better accounted for by another vestibular diagnosis)
- age > 18 years at the start of the trial.
- ≥ 4 vertigo attacks over the last 6 months.
- willing to adhere to daily trial medications and the follow-up assessments.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded:
- bilateral MD
- severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow-up.
- active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma).
- otitis media with effusion based on tympanogram results.
- history of intratympanic injections with corticosteroid less than 6 months ago.
- history of intratympanic injections with gentamicin or ear surgery for treating MD.
- pregnant women and nursing women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Centre
Leiden, South Holland, 2300RC
Maud Boreel, Msc, +31647682120, m.m.e.boreel@lumc.nl
About this study
Official title: A Multicenter, Double-blinded, Randomized, Placebo-controlled Trial to Compare the Effectiveness of Intratympanic Injections methylPREDnisolon Versus Placebo in the Treatment of Vertigo Attacks in MENière's Disease (PREDMEN Trial).
Ménière's disease is an inner ear disorder in which patients suffer from attacks of vertigo, tinnitus and hearing loss. To date, it is unclear what the best treatment for this condition is. Giving injections in the inner ear with the adrenal cortical hormone methylprednisolone is a treatment that is already widely used, but still there is insufficient evidence in the effectiveness of this treatment. This multicenter trial compares a patient group which receives injections of methylprednisolone to a patient group which receives placebo injections. Subsequently, dizziness, tinnitus, hearing loss and quality of life will be assed and compared for the above mentioned groups, over a period of one year.
Read the detailed description
Meniere's disease is an inner ear disease characterized by recurrent episodes of vertigo, hearing loss, tinnitus and aural fullness. It is estimated that 15000 patients in de Netherlands suffer from this disease. Endolymfactic hydrops is thought to be the underlying pathophysiology of the symptoms. Salt restriction, oral medication (diuretics and betahistine), intratympanic gentamicin and steroids, ablative surgery, and endolymphatic sac surgery are some of the current therapy options. A probable effectiveness of the treatment with intratympanic gentamicin is found but this treatment is ototoxic and carries a risk of hearing loss. Methylprednisolone injections have been shown to be safer, however there is insufficient data to support the efficacy of this treatment. Therefore in this double-blinded, randomized, placebo-controlled trial, effectiveness of intratympanic injections with methylPREDnisolon versus placebo in the treatment of vertigo attacks in MENière's disease is compared.
The investigators aim to include 74 patients in each arm, based on a statistical power of 80 percent. Patients will be randomly randomized to one of the two treatment arms, receiving either a placebo injection or a methylprednisolone sodium succinate injection at a dose of 62.5 mg/ml. After 14 days, this injection will be given once more. A follow-up visit will be scheduled after six and twelve months and telephone follow-up calls will be scheduled after three and nine months. The primary objective will be the control of vertigo, with secondary outcomes including hearing loss, tinnitus, the frequency of escape interventions, quality of life, adverse events and cost effectiveness.
- Conditions
- Meniere Disease
- Being tested
- Methylprednisolon, Placebo
- Keywords
- Meniere's disease, Methylprednisolon, Intratimpanic corticosteroids, Dizziness, Hearing loss, tinnitus, aural fullness, randomized control trial
- Medical subject headings
- Meniere Disease, Dizziness, Hearing Loss, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylprednisolonDrug
Intratympanal injection with Methylprednisolon 62.5 mg/ ml
PlaceboDrug
Intratympanal injection with saline, natriumchloride 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolon | Active comparator | Intratympanal injection with Methylprednisolon 62.5 mg/ ml Receives: Drug: Methylprednisolon |
| Placebo | Placebo comparator | Intratympanal injection with saline, natriumchloride 0.9% Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertigo spells
A definitive vertigo spell is defined as a spontaneous rotational vertigo symptom, which lasts at least 20 minutes and is often accompanied by disequilibrium and vomiting. No loss of consciousness is present. Vertigo spells are measured daily with the dizzy quest ap. Futhermore, at baseline after 6 and 12 months, caloric testing and a video-head impusle test are performend. Additionally the dizziness handicap inventory will be taken.
Measured: Daily, change from baseline to one year
Secondary outcomes (11)
Hearing loss
Hearing loss will be measured at baseline, 6 and 12 months after injection. Pure tone audimetry and extended fletcher index including the speech discrimination score will be tested.
Measured: At baseline, 6 months and 12 months
Tinnitus
Tinnitus will be measured with the tinnitus handicap inventory at baseline, after 6 and 12 months.
Measured: At baseline, 6 months and 12 months
health-related quality of life
The health realted quality of life will be evaluated with the generic quality of life questionnaire: EQ-5D
Measured: At baseline, 6 months and 12 months
health-related quality of life
The health realted quality of life will be evaluated with the generic quality of life questionnaire: EQ-VAS, this will be a scale from 0 to 100 in which 0 means the worst health you can imagine and 100 means the best health you can imagine
Measured: At baseline, 6 months and 12 months
Escape medication
The frequency of use of metoclopramide in the acute phase of vertigo will be registered.
Measured: At baseline, 3 months, 6 months, 9 months, 12 months
Adverse events
At each study visit, subjects will be questioned about adverse events they have experienced since the last study visit.
Measured: Daily, change from baseline to one year
Cost-effectiveness
Costs per QALY, this will be calculated from above mentioned outcomes on quality of life.
Measured: At baseline, 6 months and 12 months
Co-interventions
The use of additional methylprednisolon or gentamicine will be evaluated during the entire study.
Measured: Daily, change from baseline to one year
Overall function
The functional level scale will be measured with the questionnaire: Functional level scale: a scale from 1-6 in which 1 means: my dizziness has no effect on my activities and 6 means: I have been disabled for one year or longer and/or I received compensation (money) because of y dizziness or balance problem.
Measured: At baseline, 6 months and 12 months
Impact of Dizziness
The impact of dizziness will be measured with the questionnaire: Dizziness handicap inventory
Measured: Change from baseline to 6 months to 12 months
Tinnitus severity
The tinnitus severety will be measured with the questionnaire: Tinnitus functional index
Measured: At baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Oct 2023
- Primary completion1 May 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meniere DiseaseStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, double-blinded, randomized, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Gelre Hospitals, Maasstad Hospital, Maastricht University Medical Center, Medisch Spectrum Twente, HagaZiekenhuis
- Responsible party
- Principal investigator, Babette F van Esch, MD, PhD, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851508
- Sponsor's protocol ID
- PREDMEN
- Other IDs
- 10140022110009
- Acronym
- PREDMEN
- Status last verified
- Nov 2023
- First submitted
- 20 Feb 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data after deidentification will be shared upon reasonable request with researchers who provide a methodologically sound proposal. For analyses to achieve aims as described in the approved proposal.
Publications
Boreel MME, van Esch B, Schermer TR, Mol BM, van Benthem PP, Bruintjes TD. The effectiveness of intratympanic injections with methylPREDnisolon versus placebo in the treatment of vertigo attacks in MENiere's disease (PREDMEN trial): a study protocol for a phase-3 multicentre, double-blinded, randomised, placebo-controlled trial. BMJ Open. 2024 Aug 29;14(8):e076872. doi: 10.1136/bmjopen-2023-076872.
PubMed 39209781
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blinded, Randomized, Placebo-controlled Trial to Compare the Effectiveness of Intratympanic Injections methylPREDnisolon Versus Placebo in the Treatment of Vertigo Attacks in MENière's Disease (PREDMEN Trial).
- ClinicalTrials.gov ID
- NCT05851508
- Acronym / sponsor ID
- PREDMEN / PREDMEN
- Conditions
- Meniere Disease
- Keywords
- Meniere's disease, Methylprednisolon, Intratimpanic corticosteroids, Dizziness, Hearing loss, tinnitus, aural fullness, randomized control trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Gelre Hospitals, Maasstad Hospital, Maastricht University Medical Center, Medisch Spectrum Twente, HagaZiekenhuis
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ménière's disease is an inner ear disorder in which patients suffer from attacks of vertigo, tinnitus and hearing loss. To date, it is unclear what the best treatment for this condition is. Giving injections in the inner ear with the adrenal cortical hormone methylprednisolone is a treatment that is already widely used, but still there is insufficient evidence in the effectiveness of this treatment. This multicenter trial compares a patient group which receives injections of methylprednisolone to a patient group which receives placebo injections. Subsequently, dizziness, tinnitus, hearing loss and quality of life will be assed and compared for the above mentioned groups, over a period of one year.
Detailed description
Meniere's disease is an inner ear disease characterized by recurrent episodes of vertigo, hearing loss, tinnitus and aural fullness. It is estimated that 15000 patients in de Netherlands suffer from this disease. Endolymfactic hydrops is thought to be the underlying pathophysiology of the symptoms. Salt restriction, oral medication (diuretics and betahistine), intratympanic gentamicin and steroids, ablative surgery, and endolymphatic sac surgery are some of the current therapy options. A probable effectiveness of the treatment with intratympanic gentamicin is found but this treatment is ototoxic and carries a risk of hearing loss. Methylprednisolone injections have been shown to be safer, however there is insufficient data to support the efficacy of this treatment. Therefore in this double-blinded, randomized, placebo-controlled trial, effectiveness of intratympanic injections with methylPREDnisolon versus placebo in the treatment of vertigo attacks in MENière's disease is compared.
The investigators aim to include 74 patients in each arm, based on a statistical power of 80 percent. Patients will be randomly randomized to one of the two treatment arms, receiving either a placebo injection or a methylprednisolone sodium succinate injection at a dose of 62.5 mg/ml. After 14 days, this injection will be given once more. A follow-up visit will be scheduled after six and twelve months and telephone follow-up calls will be scheduled after three and nine months. The primary objective will be the control of vertigo, with secondary outcomes including hearing loss, tinnitus, the frequency of escape interventions, quality of life, adverse events and cost effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multicenter, double-blinded, randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolon | Active comparator | Drug: MethylprednisolonIntratympanal injection with Methylprednisolon 62.5 mg/ ml |
| Placebo | Placebo comparator | Drug: PlaceboIntratympanal injection with saline, natriumchloride 0.9% |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral, definite MD according to the diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disorders published in 2015 [7] (see Appendix 1):
- Definite MD Two or more spontaneous episodes of vertigo, each lasting 20 minutes to 12 hours, AND Audiometrically documented low- to medium-frequency sensorineural hearing loss in one ear, defining the affected ear on at least one occasion before, during or after one of the episodes of vertigo, AND Fluctuating aural symptoms (hearing, tinnitus, or fullness) in affected ear (not better accounted for by another vestibular diagnosis)
- age > 18 years at the start of the trial.
- ≥ 4 vertigo attacks over the last 6 months.
- willing to adhere to daily trial medications and the follow-up assessments.
Key exclusion criteria (8 listed)
- bilateral MD
- severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow-up.
- active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma).
- otitis media with effusion based on tympanogram results.
- history of intratympanic injections with corticosteroid less than 6 months ago.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisolonIntratympanal injection with Methylprednisolon 62.5 mg/ ml | Drug | Methylprednisolon |
| PlaceboIntratympanal injection with saline, natriumchloride 0.9% | Drug | Placebo |
Primary outcome
Vertigo spells
Time frame: Daily, change from baseline to one year
A definitive vertigo spell is defined as a spontaneous rotational vertigo symptom, which lasts at least 20 minutes and is often accompanied by disequilibrium and vomiting. No loss of consciousness is present. Vertigo spells are measured daily with the dizzy quest ap. Futhermore, at baseline after 6 and 12 months, caloric testing and a video-head impusle test are performend. Additionally the dizziness handicap inventory will be taken.
11 secondary outcomes
Hearing loss
Time frame: At baseline, 6 months and 12 months
Tinnitus
Time frame: At baseline, 6 months and 12 months
health-related quality of life
Time frame: At baseline, 6 months and 12 months
health-related quality of life
Time frame: At baseline, 6 months and 12 months
Escape medication
Time frame: At baseline, 3 months, 6 months, 9 months, 12 months
Adverse events
Time frame: Daily, change from baseline to one year
Cost-effectiveness
Time frame: At baseline, 6 months and 12 months
Co-interventions
Time frame: Daily, change from baseline to one year
Overall function
Time frame: At baseline, 6 months and 12 months
Impact of Dizziness
Time frame: Change from baseline to 6 months to 12 months
Tinnitus severity
Time frame: At baseline, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 39209781Boreel MME, van Esch B, Schermer TR, Mol BM, van Benthem PP, Bruintjes TD. The effectiveness of intratympanic injections with methylPREDnisolon versus placebo in the treatment of vertigo attacks in MENiere's disease (PREDMEN trial): a study protocol for a phase-3 multicentre, double-blinded, randomised, placebo-controlled trial. BMJ Open. 2024 Aug 29;14(8):e076872. doi: 10.1136/bmjopen-2023-076872.
- Individual participant dataSharing planned: Yes. Individual patient data after deidentification will be shared upon reasonable request with researchers who provide a methodologically sound proposal. For analyses to achieve aims as described in the approved proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolon in people with Meniere Disease, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maud Boreel, MD (+3171 526 9111, m.m.e.boreel@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertigo spells (time frame: Daily, change from baseline to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.