N/A
N=309
Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice
Vertigo
Bottom Line
View on ClinicalTrials.gov: NCT01759251 ↗Enrolled (actual)
309
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) — 43; 79; 104; 61 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) |
43; 79; 104; 61; 15; 3 | — |
| SECONDARY Change of the Patient's Clinical Conditions of Vestibular Vertigo From Baseline to the End of Observational Treatment Period |
— | — |
| SECONDARY Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period |
— | — |
| SECONDARY Change of Vestibular Vertigo Attacks Frequency From the End of Observational Treatment Period to the End of Follow-up Period |
— | — |
| SECONDARY Overall Clinical Response Assessed by Physician |
— | — |
| SECONDARY Overall Clinical Response Assessed by Patient |
— | — |
| SECONDARY Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Physician |
— | — |
| SECONDARY Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Patient |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01759251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.