Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice (VIRTUOSO)
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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 |
- 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
- 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.
| Estimated 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 |
outpatients with vestibular vertigo
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| Contact: Alexander Vladykin, PhD | +7 495 258 42 80 (ext. 57419) | alexander.vladykin@abbott.com |
| Contact: Nadiia Sotnychenko, MD | +38 050 498 60 80 (ext. 6017) | nadiia.sotnychenko@abbott.com |
| Russian Federation | |
| Site reference ID 89414 | Not yet recruiting |
| Belgorod, Russian Federation, 308007 | |
| Site reference ID 89434 | Not yet recruiting |
| Ekaterinburg, Russian Federation, 620028 | |
| Site reference ID 89433 | Not yet recruiting |
| Kazan, Russian Federation, 420012 | |
| Site reference ID 89454 | Recruiting |
| Moscow, Russian Federation, 119991 | |
| Site reference ID 91193 | Not yet recruiting |
| Moscow, Russian Federation, 125367 | |
| Site reference ID 89419 | Not yet recruiting |
| Moscow, Russian Federation, 123007 | |
| Site reference ID 89416 | Not yet recruiting |
| Moscow, Russian Federation, 129110 | |
| Site reference ID 89457 | Not yet recruiting |
| Moscow, Russian Federation, 119991 | |
| Site reference ID 94374 | Not yet recruiting |
| Moscow, Russian Federation, 127006 | |
| Site reference ID 89413 | Not yet recruiting |
| Nizhny Novgorod, Russian Federation, 603005 | |
| Site reference ID 89435 | Recruiting |
| Novosibirsk, Russian Federation, 630091 | |
| Site refernce ID 91194 | Not yet recruiting |
| Omsk, Russian Federation, 644012 | |
| Site reference ID 89453 | Recruiting |
| Rostov-on-Don, Russian Federation, 344010 | |
| Site reference ID 89418 | Recruiting |
| Saratow, Russian Federation, 410012 | |
| Site reference ID 89456 | Recruiting |
| St. Petersburg, Russian Federation, 198255 | |
| Site reference ID 89417 | Not yet recruiting |
| St. Petersburg, Russian Federation, 190013 | |
| Site reference ID 89415 | Not yet recruiting |
| Ufa, Russian Federation, 450009 | |
| Site reference ID 89455 | Not yet recruiting |
| Volgograd, Russian Federation, 400134 | |
| Site reference ID 94373 | Not yet recruiting |
| Voronezh, Russian Federation, 394066 | |
| Ukraine | |
| Site reference ID 93473 | Not yet recruiting |
| Dnipropetrovsk, Ukraine, 49027 | |
| Site reference ID 93715 | Recruiting |
| Ivano-Frankivsk, Ukraine, 76014 | |
| Site reference ID 93713 | Not yet recruiting |
| Kharkiv, Ukraine, 61000 | |
| Site reference ID 93454 | Recruiting |
| Kiev, Ukraine, 04112 | |
| Site reference ID 93453 | Not yet recruiting |
| Kyiv, Ukraine, 03057 | |
| Site reference ID 93475 | Recruiting |
| Mykolaiv, Ukraine, 54001 | |
| Site reference ID 93456 | Not yet recruiting |
| Poltava, Ukraine, 36000 | |
| Site reference ID 93714 | Recruiting |
| Sevastopol, Ukraine, 99011 | |
| Site reference ID 93474 | Recruiting |
| Simferopol, Ukraine, 95006 | |
| Site reference ID 93476 | Not yet recruiting |
| Ternopil, Ukraine, 46014 | |
| Site reference ID 95738 | Not yet recruiting |
| Zaporizhzhia, Ukraine, 69032 | |
| Site reference ID 93455 | Recruiting |
| Zaporizhzhia, Ukraine, 69060 | |
| 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: | May 27, 2013 |
| 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 June 18, 2013