Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01759251
Recruitment Status : Completed
First Posted : January 3, 2013
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Abbott

Brief 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.

Condition or disease
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).

Layout table for study information
Study Type : Observational
Actual Enrollment : 309 participants
Time Perspective: Prospective
Official Title: Post-marketing Observational Program of Betaserc® (Betahistine Dihydrochloride) to Evaluate Effectiveness in Patients With Vestibular Vertigo in Routine Practice
Study Start Date : January 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759251


Locations
Show Show 24 study locations
Sponsors and Collaborators
Abbott
Investigators
Layout table for investigator information
Study Director: Jean-Pascal Berrou, MD Abbott
Layout table for additonal information
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01759251    
Other Study ID Numbers: P13-972
First Posted: January 3, 2013    Key Record Dates
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015
Last Verified: February 2015
Keywords provided by Abbott:
Meniere Disease
Betahistine Dihydrochloride
Vertigo
Additional relevant MeSH terms:
Layout table for MeSH terms
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Sensation Disorders