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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01759251
First received: December 28, 2012
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition
Vertigo

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Post-marketing Observational Program of Betaserc® (Betahistine Dihydrochloride) to Evaluate Effectiveness in Patients With Vestibular Vertigo in Routine Practice

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
    Number and proportion of patients with clinical response on treatment determined with SVVSLCRE


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    determined with the Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)

  • Change of vestibular vertigo attacks frequency from baseline to the end of observational treatment period [ Time Frame: From Day 0 to 2 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall clinical response assessed by physician [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
    determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.

  • Overall clinical response assessed by patient [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
    determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.

  • Clinical response as improvement of vertigo associated symptoms evaluated by physician [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
    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.

  • Clinical response as improvement of vertigo associated symptoms evaluated by patient [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 310
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

outpatients with vestibular vertigo

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759251

Locations
Russian Federation
Site reference ID 89414
Belgorod, Russian Federation, 308007
Site reference ID 89434
Ekaterinburg, Russian Federation, 620028
Research facility ID ORG-000838
Irkutsk, Russian Federation, 664047
Site reference ID 89433
Kazan, Russian Federation, 420012
Site reference ID 89416
Moscow, Russian Federation, 129110
Research facility ID ORG-000837
Moscow, Russian Federation, 125047
Site reference ID 89419
Moscow, Russian Federation, 123007
Site reference ID 94374
Moscow, Russian Federation, 127006
Site reference ID 89454
Moscow, Russian Federation, 119991
Site reference ID 89457
Moscow, Russian Federation, 119991
Site reference ID 91193
Moscow, Russian Federation, 125367
Site reference ID 89413
Nizhny Novgorod, Russian Federation, 603005
Site reference ID 89435
Novosibirsk, Russian Federation, 630091
Research facility ID ORG-000841
Odintsovo, Russian Federation, 143007
Site refernce ID 91194
Omsk, Russian Federation, 644012
Site reference ID 89453
Rostov-on-Don, Russian Federation, 344010
Site reference ID 89418
Saratow, Russian Federation, 410012
Site reference ID 89417
St. Petersburg, Russian Federation, 190013
Site reference ID 89456
St. Petersburg, Russian Federation, 198255
Site reference ID 89415
Ufa, Russian Federation, 450009
Site reference ID 89455
Volgograd, Russian Federation, 400134
Site reference ID 94373
Voronezh, Russian Federation, 394066
Ukraine
Site reference ID 93473
Dnipropetrovsk, Ukraine, 49027
Research facility ID ORG-000345
Donetsk, Ukraine, 83045
Site reference ID 93715
Ivano-Frankivsk, Ukraine, 76014
Site reference ID 93713
Kharkiv, Ukraine, 61000
Site reference ID 93454
Kiev, Ukraine, 04112
Site reference ID 93453
Kyiv, Ukraine, 03057
Site reference ID 93475
Mykolaiv, Ukraine, 54001
Site reference ID 93456
Poltava, Ukraine, 36000
Site reference ID 93714
Sevastopol, Ukraine, 99011
Site reference ID 93474
Simferopol, Ukraine, 95006
Site reference ID 93476
Ternopil, Ukraine, 46014
Site reference ID 95738
Zaporizhzhia, Ukraine, 69032
Site reference ID 93455
Zaporizhzhia, Ukraine, 69060
Sponsors and Collaborators
Abbott
Investigators
Study Director: Katinka Giezeman-Smits, PhD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01759251     History of Changes
Other Study ID Numbers: P13-972
Study First Received: December 28, 2012
Last Updated: February 28, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health

Keywords provided by Abbott:
Meniere Disease
Betahistine Dihydrochloride
Vertigo

Additional relevant MeSH terms:
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders
Betahistine
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014