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

NCT01759251 | Completed Results

• 1 other identifier: P13-972
• Study Type: observational
• Target: 309
• Locations: 2 countries
• Sites: 24

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.

Conditions

Vertigo

Keywords

Meniere Disease; Betahistine Dihydrochloride; Vertigo

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change of the Patient's Clinical Conditions of Vestibular Vertigo From Baseline to the End of Observational Treatment Period

  From Day 0 to 2 months

• Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period

  From Day 0 to 2 months

• 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

• Overall Clinical Response Assessed by Physician

  up to 2 months

• Overall Clinical Response Assessed by Patient

  up to 2 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

outpatients with vestibular vertigo

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (24)

Site reference ID 89414

Belgorod, 308007, Russia

Location

Research facility ID ORG-000838

Irkutsk, 664047, Russia

Location

Site reference ID 89433

Kazan', 420012, Russia

Location

Site reference ID 89454

Moscow, 119991, Russia

Location

Site reference ID 89419

Moscow, 123007, Russia

Location

Research facility ID ORG-000837

Moscow, 125047, Russia

Location

Site reference ID 94374

Moscow, 127006, Russia

Location

Site reference ID 89416

Moscow, 129110, Russia

Location

Site reference ID 89435

Novosibirsk, 630091, Russia

Location

Research facility ID ORG-000841

Odintsovo, 143007, Russia

Location

Site reference ID 89453

Rostov-on-Don, 344010, Russia

Location

Site reference ID 89456

Saint Petersburg, 198255, Russia

Location

Site reference ID 89418

Saratov, 410012, Russia

Location

Site reference ID 89415

Ufa, 450009, Russia

Location

Site reference ID 89455

Volgograd, 400134, Russia

Location

Research facility ID ORG-000345

Donetsk, 83045, Ukraine

Location

Site reference ID 93715

Ivano-Frankivsk, 76014, Ukraine

Location

Site reference ID 93713

Kharkiv, 61000, Ukraine

Location

Site reference ID 93454

Kiev, 04112, Ukraine

Location

Site reference ID 93475

Mykolaiv, 54001, Ukraine

Location

Site reference ID 93714

Sevastopol, 99011, Ukraine

Location

Site reference ID 93474

Simferopol, 95006, Ukraine

Location

Site reference ID 95738

Zaporizhzhia, 69032, Ukraine

Location

Site reference ID 93455

Zaporizhzhia, 69060, Ukraine

Location

MeSH Terms

Conditions

Vertigo; Meniere Disease

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

4 patients had a treatment exposure of 30 days. No subgroup analyses were performed as the majority of patients had 60 days treatment with Betaserc®.

Results Point of Contact

• Title: Associate Director Clinical Services
• Organization: Abbott

taco.baardman@abbott.com

Study Officials

• Jean-Pascal Berrou, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2012
• First Posted: January 3, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 27, 2015
• Results First Posted: February 27, 2015

Record last verified: 2015-02

Locations

UA (9); RU (15)