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Completed

NCT Number: NCT01759251

Effectiveness of Betaserc® (Betahistine Dihydrochloride) 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.

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Key information

Conditions

Vertigo Ear Diseases Endolymphatic Hydrops Labyrinth Diseases Meniere Disease Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site reference ID 89414, Belgorod, Russia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    determined with the Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)

  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

    Time frame: up to 2 months

    determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.

  5. Overall Clinical Response Assessed by Patient

    Time frame: up to 2 months

    determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.

  6. Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Physician

    Time frame: up to 2 months

    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.

  7. Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Patient

    Time frame: up to 2 months

    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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

Post-marketing Observational Program of Betaserc® (Betahistine Dihydrochloride) to Evaluate Effectiveness in Patients With Vestibular Vertigo in Routine Practice

Acronym: VIRTUOSO

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 3, 2013
Registry last updated
Feb 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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