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

Vertigo Clinical Trial

— VIRTUOSO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759251
• Other study ID #: P13-972
• Status: Completed
• Phase: N/A
• First received: December 28, 2012
• Last updated: February 12, 2015
• Start date: January 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian FederationUkraine: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Dizziness
• Vertigo

Locations

Country	Name	City	State
Russian Federation	Site reference ID 89414	Belgorod
Russian Federation	Research facility ID ORG-000838	Irkutsk
Russian Federation	Site reference ID 89433	Kazan
Russian Federation	Research facility ID ORG-000837	Moscow
Russian Federation	Site reference ID 89416	Moscow
Russian Federation	Site reference ID 89419	Moscow
Russian Federation	Site reference ID 89454	Moscow
Russian Federation	Site reference ID 94374	Moscow
Russian Federation	Site reference ID 89435	Novosibirsk
Russian Federation	Research facility ID ORG-000841	Odintsovo
Russian Federation	Site reference ID 89453	Rostov-on-Don
Russian Federation	Site reference ID 89418	Saratow
Russian Federation	Site reference ID 89456	St. Petersburg
Russian Federation	Site reference ID 89415	Ufa
Russian Federation	Site reference ID 89455	Volgograd
Ukraine	Research facility ID ORG-000345	Donetsk
Ukraine	Site reference ID 93715	Ivano-Frankivsk
Ukraine	Site reference ID 93713	Kharkiv
Ukraine	Site reference ID 93454	Kiev
Ukraine	Site reference ID 93475	Mykolaiv
Ukraine	Site reference ID 93714	Sevastopol
Ukraine	Site reference ID 93474	Simferopol
Ukraine	Site reference ID 93455	Zaporizhzhia
Ukraine	Site reference ID 95738	Zaporizhzhia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period		From Day 0 to 2 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No