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The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease (PREDMEN)

Primary Purpose

Meniere Disease

Status
Recruiting
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Methylprednisolon
Placebo
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere Disease focused on measuring Meniere's disease, Methylprednisolon, Intratimpanic corticosteroids, Dizziness, Hearing loss, tinnitus, aural fullness, randomized control trial

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: • 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. Exclusion criteria 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.

Sites / Locations

  • Leiden University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylprednisolon

Placebo

Arm Description

Intratympanal injection with Methylprednisolon 62.5 mg/ ml

Intratympanal injection with saline, natriumchloride 0.9%

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Tinnitus
Tinnitus will be measured with the tinnitus handicap inventory at baseline, after 6 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
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
Escape medication
The frequency of use of metoclopramide in the acute phase of vertigo will be registered.
Adverse events
At each study visit, subjects will be questioned about adverse events they have experienced since the last study visit.
Cost-effectiveness
Costs per QALY, this will be calculated from above mentioned outcomes on quality of life.
Co-interventions
The use of additional methylprednisolon or gentamicine will be evaluated during the entire study.
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.
Impact of Dizziness
The impact of dizziness will be measured with the questionnaire: Dizziness handicap inventory
Tinnitus severity
The tinnitus severety will be measured with the questionnaire: Tinnitus functional index

Full Information

First Posted
February 20, 2023
Last Updated
October 3, 2023
Sponsor
Leiden University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Gelre Hospitals, Maasstad Hospital, Maastricht University Medical Center, Medisch Spectrum Twente, HagaZiekenhuis
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1. Study Identification

Unique Protocol Identification Number
NCT05851508
Brief Title
The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease
Acronym
PREDMEN
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).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
February 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Gelre Hospitals, Maasstad Hospital, Maastricht University Medical Center, Medisch Spectrum Twente, HagaZiekenhuis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere Disease
Keywords
Meniere's disease, Methylprednisolon, Intratimpanic corticosteroids, Dizziness, Hearing loss, tinnitus, aural fullness, randomized control trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A multicenter, double-blinded, randomized, placebo-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Trial subjects, treating physicians and outcome assessors will be blinded throughout the entire study. Pharmacy staff will be unblinded for randomization and treatment allocation. Emergency unblinding may occur in the following situations: in case of a medical emergency where knowledge of the blinded treatment is necessary, for the treatment of (serious) adverse event, in the event of a SUSAR (Suspected Unexpected Serious Adverse Reaction) needing expedited reporting or if requested by the Safety Committee.
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolon
Arm Type
Active Comparator
Arm Description
Intratympanal injection with Methylprednisolon 62.5 mg/ ml
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intratympanal injection with saline, natriumchloride 0.9%
Intervention Type
Drug
Intervention Name(s)
Methylprednisolon
Intervention Description
Intratympanal injection with Methylprednisolon 62.5 mg/ ml
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intratympanal injection with saline, natriumchloride 0.9%
Primary Outcome Measure Information:
Title
Vertigo spells
Description
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.
Time Frame
Daily, change from baseline to one year
Secondary Outcome Measure Information:
Title
Hearing loss
Description
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.
Time Frame
At baseline, 6 months and 12 months
Title
Tinnitus
Description
Tinnitus will be measured with the tinnitus handicap inventory at baseline, after 6 and 12 months.
Time Frame
At baseline, 6 months and 12 months
Title
health-related quality of life
Description
The health realted quality of life will be evaluated with the generic quality of life questionnaire: EQ-5D
Time Frame
At baseline, 6 months and 12 months
Title
health-related quality of life
Description
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
Time Frame
At baseline, 6 months and 12 months
Title
Escape medication
Description
The frequency of use of metoclopramide in the acute phase of vertigo will be registered.
Time Frame
At baseline, 3 months, 6 months, 9 months, 12 months
Title
Adverse events
Description
At each study visit, subjects will be questioned about adverse events they have experienced since the last study visit.
Time Frame
Daily, change from baseline to one year
Title
Cost-effectiveness
Description
Costs per QALY, this will be calculated from above mentioned outcomes on quality of life.
Time Frame
At baseline, 6 months and 12 months
Title
Co-interventions
Description
The use of additional methylprednisolon or gentamicine will be evaluated during the entire study.
Time Frame
Daily, change from baseline to one year
Title
Overall function
Description
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.
Time Frame
At baseline, 6 months and 12 months
Title
Impact of Dizziness
Description
The impact of dizziness will be measured with the questionnaire: Dizziness handicap inventory
Time Frame
Change from baseline to 6 months to 12 months
Title
Tinnitus severity
Description
The tinnitus severety will be measured with the questionnaire: Tinnitus functional index
Time Frame
At baseline, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: • 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. Exclusion criteria 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maud Boreel, MD
Phone
+3171 526 9111
Email
m.m.e.boreel@lumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Babette van Esch, MD, PHD
Phone
+3171 526 9111
Email
b.f.van_esch@lumc.nl
Facility Information:
Facility Name
Leiden University Medical Centre
City
Leiden
State/Province
Zuid Holland
ZIP/Postal Code
2300RC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maud Boreel, Msc
Phone
+31647682120
Email
m.m.e.boreel@lumc.nl

12. IPD Sharing Statement

Learn more about this trial

The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease

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