VertigoVIRTUOSONCT01759251
Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice
An observational study of Vertigo, run by Abbott at 24 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertigo
- How many people
- 309 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Jan 2013to May 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatients with vestibular vertigo
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
Russia15 sites
Site reference ID 89414
Belgorod, 308007
Research facility ID ORG-000838
Irkutsk, 664047
Site reference ID 89433
Kazan', 420012
Site reference ID 89454
Moscow, 119991
Site reference ID 89419
Moscow, 123007
Research facility ID ORG-000837
Moscow, 125047
Site reference ID 94374
Moscow, 127006
Site reference ID 89416
Moscow, 129110
Site reference ID 89435
Novosibirsk, 630091
Research facility ID ORG-000841
Odintsovo, 143007
Site reference ID 89453
Rostov-on-Don, 344010
Site reference ID 89456
Saint Petersburg, 198255
Site reference ID 89418
Saratov, 410012
Site reference ID 89415
Ufa, 450009
Site reference ID 89455
Volgograd, 400134
Ukraine9 sites
Research facility ID ORG-000345
Donetsk, 83045
Site reference ID 93715
Ivano-Frankivsk, 76014
Site reference ID 93713
Kharkiv, 61000
Site reference ID 93454
Kiev, 04112
Site reference ID 93475
Mykolaiv, 54001
Site reference ID 93714
Sevastopol, 99011
Site reference ID 93474
Simferopol, 95006
Site reference ID 95738
Zaporizhzhya, 69032
Site reference ID 93455
Zaporizhzhya, 69060
About this study
Official title: Post-marketing Observational Program of Betaserc® (Betahistine Dihydrochloride) to Evaluate Effectiveness in Patients With Vestibular Vertigo in Routine Practice
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.
Read the 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).
- Conditions
- Vertigo
- Keywords
- Meniere Disease, Betahistine Dihydrochloride, Vertigo
- Medical subject headings
- Vertigo, Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)
Number of patients with clinical response on treatment determined with SVVSLCRE
Measured: Up to 2 months
Secondary outcomes (7)
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)
Measured: From Day 0 to 2 months
Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Pascal Berrou, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759251
- Sponsor's protocol ID
- P13-972
- Acronym
- VIRTUOSO
- Status last verified
- Feb 2015
- First submitted
- 28 Dec 2012
- Last updated
- 27 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Observational Program of Betaserc® (Betahistine Dihydrochloride) to Evaluate Effectiveness in Patients With Vestibular Vertigo in Routine Practice
- ClinicalTrials.gov ID
- NCT01759251
- Acronym / sponsor ID
- VIRTUOSO / P13-972
- Conditions
- Vertigo
- Keywords
- Meniere Disease, Betahistine Dihydrochloride, Vertigo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Posted 27 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients with vestibular vertigo
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)
Time frame: Up to 2 months
Number of patients with clinical response on treatment determined with SVVSLCRE
7 secondary outcomes
Change of the Patient's Clinical Conditions of Vestibular Vertigo From Baseline to the End of Observational Treatment Period
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
Time frame: up to 2 months
Overall Clinical Response Assessed by Patient
Time frame: up to 2 months
Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Physician
Time frame: up to 2 months
Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Patient
Time frame: up to 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pascal Berrou, MD study director
Abbott
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo, run by Abbott at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Russia, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015.