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

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.

Study Overview

• Status: Completed
• Conditions: Vertigo

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 Type: Observational
• Enrollment (Actual): 309

Contacts and Locations

Study Locations

• Russian Federation
  • Belgorod, Russian Federation, 308007
    • Site reference ID 89414
  • Irkutsk, Russian Federation, 664047
    • Research facility ID ORG-000838
  • Kazan, Russian Federation, 420012
    • Site reference ID 89433
  • Moscow, Russian Federation, 119991
    • Site reference ID 89454
  • Moscow, Russian Federation, 123007
    • Site reference ID 89419
  • Moscow, Russian Federation, 125047
    • Research facility ID ORG-000837
  • Moscow, Russian Federation, 127006
    • Site reference ID 94374
  • Moscow, Russian Federation, 129110
    • Site reference ID 89416
  • Novosibirsk, Russian Federation, 630091
    • Site reference ID 89435
  • Odintsovo, Russian Federation, 143007
    • Research facility ID ORG-000841
  • Rostov-on-Don, Russian Federation, 344010
    • Site reference ID 89453
  • Saratow, Russian Federation, 410012
    • Site reference ID 89418
  • St. Petersburg, Russian Federation, 198255
    • Site reference ID 89456
  • Ufa, Russian Federation, 450009
    • Site reference ID 89415
  • Volgograd, Russian Federation, 400134
    • Site reference ID 89455
• Ukraine
  • Donetsk, Ukraine, 83045
    • Research facility ID ORG-000345
  • Ivano-Frankivsk, Ukraine, 76014
    • Site reference ID 93715
  • Kharkiv, Ukraine, 61000
    • Site reference ID 93713
  • Kiev, Ukraine, 04112
    • Site reference ID 93454
  • Mykolaiv, Ukraine, 54001
    • Site reference ID 93475
  • Sevastopol, Ukraine, 99011
    • Site reference ID 93714
  • Simferopol, Ukraine, 95006
    • Site reference ID 93474
  • Zaporizhzhia, Ukraine, 69032
    • Site reference ID 95738
  • Zaporizhzhia, Ukraine, 69060
    • Site reference ID 93455

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatients with vestibular vertigo

Description

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.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Jean-Pascal Berrou, MD, Abbott

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: December 28, 2012
• First Submitted That Met QC Criteria: December 28, 2012
• First Posted (Estimate): January 3, 2013

Study Record Updates

• Last Update Posted (Estimate): February 27, 2015
• Last Update Submitted That Met QC Criteria: February 12, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Vertigo; Meniere Disease; Betahistine Dihydrochloride
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness
• Other Study ID Numbers: P13-972