Efficacy and safety of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg vs betahistine dihydrochloride 16 mg in patients with inner ear vertigo.

Efficacy and safety of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg vs betahistine dihydrochloride 16 mg in patients with vertigo of peripheral origin. A multi-centre, double-blind, randomised, active-controlled, stratified two-parallel group clinical study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004025-27-AT

Enrollment

224

Registered

2012-10-17

Start date

2013-02-15

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertigo of peripheral origin MedDRA version: 15.0 Level: LLT Classification code 10031615 Term: Other and unspecified peripheral vertigo System Organ Class: 10013993 - Ear and labyrinth disorders MedDRA version: 14.1 Level: LLT Classification code 10058708 Term: Rotatory vertigo System Organ Class: 10013993 - Ear and labyrinth disorders MedDRA version: 14.1 Level: PT Classification code 10047344 Term: Vertigo labyrinthine System Organ Class: 10013993 - Ear and labyrinth disorders MedDRA vers

Interventions

Trade Name: Arlevert® 20 mg/ 40 mg Tabletten Pharmaceutical Form: Tablet INN or Proposed INN: CINNARIZINE CAS Number: 298-57-7 Other descriptive name: CINNARIZINE Concentration unit: mg milligram(s) C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: caucasian written Informed Consent of the patient age = 18 patient has vertigo sensations of peripheral-vestibular origin, e.g. Menière-like symptoms Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 178 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46

Exclusion criteria

Exclusion criteria: simultaneous participation in another clinical study patient did not voluntarily sign the informed consent form intake of antivertiginous or cerebrovascularly active medication that cannot be discontinued known allergic reactions to one of the active substances of the study medication (cinnarizine, dimenhydrinate and/or betahistine dihydrochloride) known hypersensitivity to various medicaments suspicion of alcohol and/or drug abuse psychiatric diseases, insanity epilepsy or convulsive fits acute infections severe chronic or terminal diseases (cancer, tuberculosis) any disease that could affect absorption, metabolism or elimination of the study medication acute poisoning suspected pregnancy / nursing period / women of child-bearing potential, if no safe contraception can be guaranteed during the study chronic inflammatory middle ear diseases Parkinson’s disease suspected compressive intracranial processes suspected narrow-angle glaucoma suspected prostate adenoma with formation of residual urine in the bladder severe renal insufficiency chronic liver disease treatment with aminoglycosidic antibiotics treatment with monoaminooxidase inhibitors, tricyclic antidepressants, para-sympatholytics, glucocorticoids and/or heparin that cannot be discontinued phaeochromocytoma peptic ulcer

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to demonstrate that the antivertiginous efficacy of the fixed combination cinnarizine/dimenhydrinate is non-inferior to betahistine dihydrochloride 16 mg in patients suffering from vertigo of peripheral origin.;Secondary Objective: Changes in Mean Vertigo Score after 1 week of therapy Changes in the intensity of 6 unprovoked vertigo symptoms and of vertigo in consequence of 6 various triggering factors, of vegetative and other concomitant symptoms and of further complaints during the treatment Changes in parameters of vestibulo-spinal and vestibulo-ocular tests during the treatment Evaluation of global efficacy by both the investigator and the patient (5-point scale) Evaluation of the patient’s ability to cope with daily activities (3-point scale);Primary end point(s): The primary endpoint is the change in the Mean Vertigo Score (MVS) from Baseline to Week 4, defined as the mean of the intensities of six unprovoked vertigo symptoms (dystasia and walking unsteadiness, staggering, rotary sensation, tendency to fall, lift sensation and blackout) and of vertigo in consequence of six triggering factors (change of position, bowing, getting up, driving by car/train, head movements, and eye movement), as subjectively judged by the patient.;Timepoint(s) of evaluation of this end point: baseline and after 4 weeks of treatment	—

Measure

Time frame

Main Objective: The main objective is to demonstrate that the antivertiginous efficacy of the fixed combination cinnarizine/dimenhydrinate is non-inferior to betahistine dihydrochloride 16 mg in patients suffering from vertigo of peripheral origin.;Secondary Objective: Changes in Mean Vertigo Score after 1 week of therapy Changes in the intensity of 6 unprovoked vertigo symptoms and of vertigo in consequence of 6 various triggering factors, of vegetative and other concomitant symptoms and of further complaints during the treatment Changes in parameters of vestibulo-spinal and vestibulo-ocular tests during the treatment Evaluation of global efficacy by both the investigator and the patient (5-point scale) Evaluation of the patient’s ability to cope with daily activities (3-point scale);Primary end point(s): The primary endpoint is the change in the Mean Vertigo Score (MVS) from Baseline to Week 4, defined as the mean of the intensities of six unprovoked vertigo symptoms (dystasia and walking unsteadiness, staggering, rotary sensation, tendency to fall, lift sensation and blackout) and of vertigo in consequence of six triggering factors (change of position, bowing, getting up, driving by car/train, head movements, and eye movement), as subjectively judged by the patient.;Timepoint(s) of evaluation of this end point: baseline and after 4 weeks of treatment

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Secondary

Measure	Time frame
Secondary end point(s): Changes in Mean Vertigo Score after 1 week of therapy Changes in the intensity of 6 unprovoked vertigo symptoms and of vertigo in consequence of 6 various triggering factors, of vegetative and other concomitant symptoms and of further complaints during the treatment Changes in parameters of vestibulo-spinal and vestibulo-ocular tests during the treatment Evaluation of global efficacy by both the investigator and the patient (5-point scale) Evaluation of the patient’s ability to cope with daily activities (3-point scale);Timepoint(s) of evaluation of this end point: baseline, after 1 week and after 4 weeks of treatment	—

Measure

Time frame

Secondary end point(s): Changes in Mean Vertigo Score after 1 week of therapy Changes in the intensity of 6 unprovoked vertigo symptoms and of vertigo in consequence of 6 various triggering factors, of vegetative and other concomitant symptoms and of further complaints during the treatment Changes in parameters of vestibulo-spinal and vestibulo-ocular tests during the treatment Evaluation of global efficacy by both the investigator and the patient (5-point scale) Evaluation of the patient’s ability to cope with daily activities (3-point scale);Timepoint(s) of evaluation of this end point: baseline, after 1 week and after 4 weeks of treatment

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Countries

Austria, Bulgaria, Czech Republic, Russian Federation

Contacts

Public ContactClinical Trials Information

HENNIG ARZNEIMITTEL GmbH & Co. KG

clinical-trials@hennig-am.de+4961455080

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026