Vertigo
Conditions
Keywords
Meniere Disease, Betahistine Dihydrochloride, Vertigo
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
Abbott
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) | Up to 2 months | Number of patients with clinical response on treatment determined with SVVSLCRE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period | 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 | From 2 months to 4 months | — |
| Overall Clinical Response Assessed by Physician | up to 2 months | determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor. |
| Change of the Patient's Clinical Conditions of Vestibular Vertigo From Baseline to the End of Observational Treatment Period | From Day 0 to 2 months | determined with the Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) |
| Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Physician | up to 2 months | 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. |
| Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Patient | up to 2 months | 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. |
| Overall Clinical Response Assessed by Patient | up to 2 months | determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor. |
Countries
Russia, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vestibular Vertigo Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label | 309 |
| Total | 309 |
Baseline characteristics
| Characteristic | Vestibular Vertigo |
|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 15.1 |
| Region of Enrollment Russian Federation | 207 participants |
| Region of Enrollment Ukraine | 102 participants |
| Sex: Female, Male Female | 220 Participants |
| Sex: Female, Male Male | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 309 |
| serious Total, serious adverse events | 0 / 309 |
Outcome results
Primary
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
Population: 60 days treatment group
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vestibular Vertigo | Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) | excellent | 43 participants |
| Vestibular Vertigo | Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) | very good | 79 participants |
| Vestibular Vertigo | Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) | good | 104 participants |
| Vestibular Vertigo | Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) | moderate | 61 participants |
| Vestibular Vertigo | Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) | no change | 15 participants |
| Vestibular Vertigo | Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) | worsening | 3 participants |
Secondary
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
Secondary
Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period
Time frame: From Day 0 to 2 months
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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