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CompletedNCT01759251VIRTUOSOUpdated Feb 27, 2015Results posted

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

An observational study in Vertigo, sponsored by Abbott. Completed at 24 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-27.

Sponsored by Abbott · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
309
Ages
18 Years and older
Sex
All
01

Study 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.

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).

02

Conditions studied

  • Vertigo

Keywords

  • Meniere Disease
  • Betahistine Dihydrochloride
  • Vertigo
03

In context

Vertigo

250 studies on the registry are indexed under Vertigo; 39 are open to participants now.

This study's enrollment of 309 is above the median of 151 across 51 observational studies indexed under Vertigo.

Browse Vertigo studies →

Lead sponsor

Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.

Browse Abbott studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

outpatients with vestibular vertigo

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Time perspective
Prospective
Enrollment
309 participants (actual)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

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

    Time frame: From Day 0 to 2 months

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

07

Results

Posted Feb 27, 2015
Limitations and caveats
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®.

Participant flow

30 Days Treatment Period
Participant flow — 30 Days Treatment Period
MilestoneVestibular Vertigo
Started309
Completed305
Not completed4
60 Days Treatment Period
Participant flow — 60 Days Treatment Period
MilestoneVestibular Vertigo
Started305
Completed305
Not completed0
Follow-up Period
Participant flow — Follow-up Period
MilestoneVestibular Vertigo
Started305
Completed305
Not completed0

Outcome measures

PrimaryScale 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
Reported as:
Number · participants
Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)
participantsVestibular Vertigo
excellent43
very good79
good104
moderate61
no change15
worsening3
SecondaryChange 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

Results for this outcome have not been posted.

SecondaryChange of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period
Time frame:
From Day 0 to 2 months

Results for this outcome have not been posted.

SecondaryChange 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

Results for this outcome have not been posted.

SecondaryOverall 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

Results for this outcome have not been posted.

SecondaryOverall 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

Results for this outcome have not been posted.

SecondaryClinical 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

Results for this outcome have not been posted.

SecondaryClinical 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

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vestibular Vertigo—0/309 (0%)0/309 (0%)

Baseline characteristics

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.

Age, Continuous
Age, Continuous(years)Vestibular Vertigo
Mean53.5 ± 15.1
Sex: Female, Male
Sex: Female, Male(Participants)Vestibular Vertigo
Female220
Male89
Region of Enrollment
Region of Enrollment(participants)Vestibular Vertigo
Ukraine102
Russian Federation207
08

Study locations

24 sites
  • Site reference ID 89414
    Belgorod, 308007, Russia
  • Research facility ID ORG-000838
    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
    Zaporizhzhya, 69032, Ukraine
  • Site reference ID 93455
    Zaporizhzhya, 69060, Ukraine
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2013, a primary completion of May 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Feb 2015, 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 28, 2012
First posted
Jan 3, 2013
Start
Jan 2013
Primary completionActual
May 2014
CompletionActual
May 2014
Results first posted
Feb 27, 2015
Last update
Feb 27, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01759251
Lead sponsor
Abbott
Responsible party
Sponsor
First posted
Jan 3, 2013
Start date
Jan 2013
Primary completion
May 2014
Completion
May 2014
Results posted
Feb 27, 2015
Last update
Feb 27, 2015

Study contacts

Jean-Pascal Berrou, MD
study director · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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