BridgeMD
A Multicenter, Two-arm, Double-blind, Double dummy, Parallel-group Study for efficacy and safety evaluation of prolonged release formulation of Betahistine PR 48 mg once daily in comparison with conventional release formulation of Betahistine IR 24 mg, twice daily in treatment of adult patients with Menière's disease
EU CTIS ID: 2024-518347-38-00
What this study is testing
To prove non-inferiority in terms of efficacy for the test product (betahistine PR 48 mg once daily) with that of reference product (Betaserc IR 24 mg twice daily) for treatment of patients with Meniere’s disease (symptoms of which may include nausea and vomiting, tinnitus and hearing loss).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or non-pregnant female patients ≥18 years of age.
- Patient has a diagnosis of unilateral definite Meniere's disease by 1995 American Academy of Otolaryngology — Head and Neck Surgery (AAOHNS) criteria and reports history of frequent attacks of active vertigo on betahistine (soon after the start of an acute attack of vertigo) prior to the study lead-in/wash-out period
- Patient as • a naïve patient who has experienced active vertigo of significant severity (defined as a score ≥7 points according to Intensity (V), Duration (D) and Frequency of the crisis (F) ítems of the GISFaV self-rating scale) during the month prior to inclusion in the trial • or a pretreated patient with betahistine IR <48 mg/day who has experienced active vertigo of significant severity (defined as a score ≥5 points according to Intensity (V), Duration (D) and Frequency of the crisis (F) ítems of the GISFaV self-rating scale) during the month prior to inclusion in the trial • or a pretreated patient with betahistine IR = 48 mg/day who has experienced active vertigo of any severity during the month prior to inclusion in the trial
- Patient has documented asymmetric sensorineural hearing loss.
- Patients currently on a low salt diet at the time of screening agree to continue this low-salt diet throughout the study.
- Patients who withdrawal of interfering concomitant therapies at least 7 days before the start of the study treatment. The following are considered concomitant therapies: other agents for peripheral vestibular vertigo (diuretics, trans tympanic gentamycin, cinnarizine, competitive antagonist of histamine, blocking H1- histamine receptors), drugs that act on cerebral circulation, antihistamines, calcium antagonists, antiagregant, thiazide diuretics, corticosteroids and benzodiazepines.
You likely can't join if
- Patient is pregnant or lactating.
- Patient has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
- History of tympanostomy tubes with evidence of perforation or lack of closure.
- Patient has experienced an adverse reaction to IT injection of steroids.
- Patient has used an investigational drug or device in 3 months prior to screening.
- Patients with hypersensitivity to the active substance or to any of the excipients of the study drug.
See the full eligibility criteria
Who can join
- Male or non-pregnant female patients ≥18 years of age.
- Patient has a diagnosis of unilateral definite Meniere's disease by 1995 American Academy of Otolaryngology — Head and Neck Surgery (AAOHNS) criteria and reports history of frequent attacks of active vertigo on betahistine (soon after the start of an acute attack of vertigo) prior to the study lead-in/wash-out period
- Patient as • a naïve patient who has experienced active vertigo of significant severity (defined as a score ≥7 points according to Intensity (V), Duration (D) and Frequency of the crisis (F) ítems of the GISFaV self-rating scale) during the month prior to inclusion in the trial • or a pretreated patient with betahistine IR <48 mg/day who has experienced active vertigo of significant severity (defined as a score ≥5 points according to Intensity (V), Duration (D) and Frequency of the crisis (F) ítems of the GISFaV self-rating scale) during the month prior to inclusion in the trial • or a pretreated patient with betahistine IR = 48 mg/day who has experienced active vertigo of any severity during the month prior to inclusion in the trial
- Patient has documented asymmetric sensorineural hearing loss.
- Patients currently on a low salt diet at the time of screening agree to continue this low-salt diet throughout the study.
- Patients who withdrawal of interfering concomitant therapies at least 7 days before the start of the study treatment. The following are considered concomitant therapies: other agents for peripheral vestibular vertigo (diuretics, trans tympanic gentamycin, cinnarizine, competitive antagonist of histamine, blocking H1- histamine receptors), drugs that act on cerebral circulation, antihistamines, calcium antagonists, antiagregant, thiazide diuretics, corticosteroids and benzodiazepines.
- Women with child-bearing potential should have a negative serum pregnancy test at screening visit at the start of the treatment. Such females and their partners should be ready to adopt required measures to avoid conception throughout the study participation. Detailed information in section 8.1.7
- Informed consent as obtained in Section 11.3 of the protocol.
What rules you out
- Patient is pregnant or lactating.
- Patient has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
- History of tympanostomy tubes with evidence of perforation or lack of closure.
- Patient has experienced an adverse reaction to IT injection of steroids.
- Patient has used an investigational drug or device in 3 months prior to screening.
- Patients with hypersensitivity to the active substance or to any of the excipients of the study drug.
- Patients with pheochromocytoma.
- Patients with asthmatic bronchitis, bronchial asthma, urticaria, exanthema or allergic rhinitis.
- Patients with pronounced hypotension.
- Patients under treatment with MAO inhibitors (including MAO-B selective).
- Patients with any major medical or surgical condition likely to interfere with the absorption, distribution, metabolism or excretion of the drug used in the study or with a terminal disease.
- Patient with middle or inner ear infection.
- Patients with vestibular disorders other than Meniere’s disease such as benign paroxysmal positional vertigo perilymph fistula, vestibular neuronitis, viral labyrinthitis, benign paroxysmal vertigo of childhood, otosclerosis, giddiness of ischemic or neck origin together with a sensorineural hearing loss, cholesteatoma and fistula formation, disequilibrium after head injury, drug toxicity, vestibular neuroma, multiple sclerosis, cardiovascular disturbances, craniocervical dysplasia, syphilis and Cogan's syndrome
- Patient with history of middle or inner ear surgery.
- Paciente con antecedentes o presencia de alcoholismo significativo o abuso de drogas en el último año.
- Patients with psychiatric or significant neurological disorders, spinal cord damage, use of any other agents for Meniere's disease.
- Patients with ear surgery for vestibular disorders.
- Patients with peptic ulcer (including a history of this disorder).
- Patient has a history of immunodeficiency disease.
- Patient has a history of previous endolymphatic sac surgery.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.