Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice

Abbott309 enrolled

Overview

The purposes of this international post-marketing observational program is to investigate effectiveness of betahistine dihydrochloride (Betaserc®) tablets and assess the course of vestibular vertigo after treatment discontinuation in population of Russia and Ukraine outpatients suffering from vestibular vertigo in pragmatic clinical settings. Exploratory analyses of results from both participating countries may be expected to provide insights about the subjective circumstances of vestibular vertigo patients in a wider than usual range of gender, underlying ICD-10 diagnosis, national and cultural situations.

A prospective, multicentre, non-interventional, non-randomized, non-controlled, single arm, post-marketing observational program in patients whom betahistine dihydrochloride (Betaserc®) tablets were prescribed in the usual manner at the maximal recommended daily dose of 48 mg in accordance with the locally approved label. Over a program period physician is free to adjust betahistine dihydrochloride dose according to country approved label. Adult outpatients with vestibular vertigo who can be treated with betahistine dihydrochloride as per the locally approved label will be enrolled in the program. The program consists of an observational treatment period (up to 2 months) and a follow-up period (up to 2 months, for evaluation of the course of vestibular vertigo after treatment completion).

Study Type

OBSERVATIONAL

Enrollment

309

Conditions

Vertigo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * Male or female 18 years and older. * Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe 48 mg of betahistine dihydrochloride (Betaserc®) in accordance with locally approved label. * Patients who are willing and able to provide authorization to the investigator to use and/or disclose personal and/or health data. * Patients who started betahistine dihydrochloride (Betaserc®) therapy not more than 5 days priory to sign Patient Authorization (Consent) for Use/Disclosure of Data. Exclusion Criteria * Patients with any condition which, in the opinion of the Investigator, makes the patient unsuitable for inclusion based on clinical judgment. * Labeled contraindications of betahistine dihydrochloride (Betaserc®) treatment. * Patients with middle or inner ear infection. * Patient with psychiatric disorders, significant neurological disorder or spinal cord damage. * Patients receiving any other agents for peripheral vestibular vertigo such as diuretics, transtympanic gentamycin, cinnarizine, competitive antagonist of histamine, blocking H1- histamine receptors.

Locations (24)

Site reference ID 89414

Belgorod, Russia

Research facility ID ORG-000838

Irkutsk, Russia

Site reference ID 89433

Kazan', Russia

Site reference ID 89454

Moscow, Russia

Site reference ID 89419

Moscow, Russia

Research facility ID ORG-000837

Moscow, Russia

Site reference ID 94374

Moscow, Russia

Site reference ID 89416

Moscow, Russia

Site reference ID 89435

Novosibirsk, Russia

Research facility ID ORG-000841

Odintsovo, Russia

...and 14 more locations

Outcomes

Primary Outcomes

Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)

Number of patients with clinical response on treatment determined with SVVSLCRE

Time frame: Up to 2 months

Secondary Outcomes

Change of the Patient's Clinical Conditions of Vestibular Vertigo From Baseline to the End of Observational Treatment Period

determined with the Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)

Time frame: From Day 0 to 2 months

Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period

Time frame: From Day 0 to 2 months

Change of Vestibular Vertigo Attacks Frequency From the End of Observational Treatment Period to the End of Follow-up Period

Time frame: From 2 months to 4 months

Overall Clinical Response Assessed by Physician

determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.

Time frame: up to 2 months

Overall Clinical Response Assessed by Patient

determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.

Time frame: up to 2 months

Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Physician

vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.

Time frame: up to 2 months

Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Patient

vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.

Time frame: up to 2 months