A multicenter, double-blinded, randomized, placebo-controlled trial to compare the effectiveness of intratympanic injections methylPREDnisolone versus placebo in the treatment of vertigo attacks in MENière’s disease (PREDMEN trial).

Conditions

Menière's disease

Brief summary

Complete or substantial control of vertigo (Class A or B).

Detailed description

Frequency of intratympanic injections with either gentamicin or corticosteroid (methylprednisolone, dexamethasone, triamcinolone), Pure tone audiometry, Quality of life determined by the EQ-5D-5L questionnaire (EQ-5D and EQ-VAS scores), Dizziness related quality of life as determined by the DHI and FLS questionnaires, Tinnitus related quality of life as determined by the TFI questionnaires, (Serious) Adverse events, SUSARs, Cost effectiveness and cost-utility, Frequency of use of metoclopramide

Maud Boreel, Babette F. van Esch, Tjard Schermer, Berber M Mol, Peter Paul G. van Benthem et al. (6 authors)

BMJ Open2024-08-012 citations

10.1136/bmjopen-2023-076872

Interventions

DRUGSolu-Medrol 62

DRUG5 mg/ml

DRUGpoeder en oplosmiddel voor oplossing voor injectie

DRUGDexamethason CF 20 mg/ml

DRUGinjectievloeistof

DRUGKenacort-A 40

DRUGsuspensie voor injectie 40 mg/ml

DRUGPRIMPERAN 10 mg

DRUGsuppositoire sécable

DRUGGentamicine CF 40 mg/ml

DRUGNatriumchloride 0

DRUG9 %

DRUGoplossing voor injectie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete or substantial control of vertigo (Class A or B).	—

Secondary

Measure	Time frame
Frequency of intratympanic injections with either gentamicin or corticosteroid (methylprednisolone, dexamethasone, triamcinolone), Pure tone audiometry, Quality of life determined by the EQ-5D-5L questionnaire (EQ-5D and EQ-VAS scores), Dizziness related quality of life as determined by the DHI and FLS questionnaires, Tinnitus related quality of life as determined by the TFI questionnaires, (Serious) Adverse events, SUSARs, Cost effectiveness and cost-utility, Frequency of use of metoclopramide	—

Measure

Time frame

Frequency of intratympanic injections with either gentamicin or corticosteroid (methylprednisolone, dexamethasone, triamcinolone), Pure tone audiometry, Quality of life determined by the EQ-5D-5L questionnaire (EQ-5D and EQ-VAS scores), Dizziness related quality of life as determined by the DHI and FLS questionnaires, Tinnitus related quality of life as determined by the TFI questionnaires, (Serious) Adverse events, SUSARs, Cost effectiveness and cost-utility, Frequency of use of metoclopramide

—

Countries

Netherlands

Outcome results

None listed