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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) | Number of patients with clinical response on treatment determined with SVVSLCRE | Up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From Day 0 to 2 months |
| Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period |
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Inclusion Criteria
Exclusion Criteria
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outpatients with vestibular vertigo
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pascal Berrou, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site reference ID 89414 | Belgorod | 308007 | Russia | |||
| Research facility ID ORG-000838 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 30 Days Treatment Period |
|
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| 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 | determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor. | 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. | 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. | 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. | up to 2 months |
| Irkutsk |
| 664047 |
| Russia |
| Site reference ID 89433 | Kazan' | 420012 | Russia |
| Site reference ID 89454 | Moscow | 119991 | Russia |
| Site reference ID 89419 | Moscow | 123007 | Russia |
| Research facility ID ORG-000837 | Moscow | 125047 | Russia |
| Site reference ID 94374 | Moscow | 127006 | Russia |
| Site reference ID 89416 | Moscow | 129110 | Russia |
| Site reference ID 89435 | Novosibirsk | 630091 | Russia |
| Research facility ID ORG-000841 | Odintsovo | 143007 | Russia |
| Site reference ID 89453 | Rostov-on-Don | 344010 | Russia |
| Site reference ID 89456 | Saint Petersburg | 198255 | Russia |
| Site reference ID 89418 | Saratov | 410012 | Russia |
| Site reference ID 89415 | Ufa | 450009 | Russia |
| Site reference ID 89455 | Volgograd | 400134 | Russia |
| Research facility ID ORG-000345 | Donetsk | 83045 | Ukraine |
| Site reference ID 93715 | Ivano-Frankivsk | 76014 | Ukraine |
| Site reference ID 93713 | Kharkiv | 61000 | Ukraine |
| Site reference ID 93454 | Kiev | 04112 | Ukraine |
| Site reference ID 93475 | Mykolaiv | 54001 | Ukraine |
| Site reference ID 93714 | Sevastopol | 99011 | Ukraine |
| Site reference ID 93474 | Simferopol | 95006 | Ukraine |
| Site reference ID 95738 | Zaporizhzhia | 69032 | Ukraine |
| Site reference ID 93455 | Zaporizhzhia | 69060 | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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| 60 Days Treatment Period |
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| Follow-up Period |
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Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe 48 mg of Betaserc® in accordance with locally approved label.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) | Number of patients with clinical response on treatment determined with SVVSLCRE | 60 days treatment group | Posted | Number | participants | Up to 2 months |
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| 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) | Not Posted | From Day 0 to 2 months | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period | Not Posted | 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 | Not Posted | From 2 months to 4 months | |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Clinical Response Assessed by Physician | determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor. | Not Posted | 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. | Not Posted | 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. | Not Posted | up to 2 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. | Not Posted | up to 2 months |
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Serious adverse events will be reported to Abbott from the time the physician obtains the patient's authorization to use and disclose information (or the patient's informed consent) until 30 days following the intake of the last dose of physician-prescribed treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 309 | 0 | 309 |
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4 patients had a treatment exposure of 30 days. No subgroup analyses were performed as the majority of patients had 60 days treatment with Betaserc®.
Investigator shall not publish /present the results without Abbott's prior written consent. In the event that applicable law permits Investigator to publish or present results without Abbott's prior written consent, Investigator shall provide Abbott with a complete copy of such publication or presentation at least 60 days prior to submission for publication or presentation and Investigator shall reasonably consider all comments which Abbott may provide regarding such publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director Clinical Services | Abbott | taco.baardman@abbott.com |
| ID | Term |
|---|---|
| D014717 | Vertigo |
| D008575 | Meniere Disease |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018159 | Endolymphatic Hydrops |
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| Title | Measurements |
|---|
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| moderate |
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| no change |
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| worsening |
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