Effect of V0251 in Acute Vertigo
October 29, 2014 updated by: Pierre Fabre Medicament
Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.
Study Overview
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hradec Králové, Czech Republic
- Fakultni nemocnice Hradec Kralove
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Kladno, Czech Republic
- Regional Hospital Kladno
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Ostrava, Czech Republic
- Faculty Hospital Ostrava
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Praha, Czech Republic
- Faculty Hospital Kralovske Vinohrady
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Praha, Czech Republic
- Faculty Hospital Motol
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Praha, Czech Republic
- Thomayer's Teaching Hospital
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Prostejov, Czech Republic
- Strepomrauska Nemocaicni a. S.
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Elbeuf, France
- CHI Elbeuf-Louviers-Val de Reuil
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Marseille, France
- Hopital Nord
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Rouen, France
- CHU de Rouen, Hôpital Charles Nicolle
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St Etienne, France
- Hopital Nord
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Toulouse, France
- Hopital Purpan
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Aachen, Germany
- Universitätsklinikum Aachen
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Berlin, Germany
- Helios Klinikum Berlin-Buch
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Berlin, Germany
- Park - Klinik Weissensee
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Celle, Germany
- Allgemeines Krankenhaus Celle
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Essen, Germany
- Universitatsklinikum Essen
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Frankfurt Am Main, Germany
- Goethe-University
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Lübeck, Germany
- Universitätsklinikum Schleswig-Holstein Campus Lübeck
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Mannheim, Germany
- University Hospital Mannheim
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München, Germany
- Universitätsklinikum München
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Budapest, Hungary
- Semmelweis Egyetem Neurologiai Klinika
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Debrecen, Hungary
- Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
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Gyor, Hungary
- Petz Aladar Megyei Oktato Korhaz
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Kaposvar, Hungary
- Kaposi Mór Megyei Oktató Kórhaz
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Miskolc, Hungary
- Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
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Nagykanizsa, Hungary
- Kanizsai Dorottya Korhaz
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Pecs, Hungary
- Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
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Sopron, Hungary
- Soproni Erzsébet Oktató Kórház
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Szombathely, Hungary
- Markusovszky County Hospital
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Badajoz, Spain
- Complejo H.Universitario de Badajoz
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El Ejido, Spain
- Hospital de Poniente
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GETAFE -Madrid, Spain
- Hospital Universitario de Getafe
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Linares, Spain
- Hospital Comarcal San Agustin
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Madrid, Spain
- Hospital Gregorio Marañón
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Pamplona, Spain
- Clinica Universitaria de Navarra
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Pontevedra, Spain
- Complejo Hospitalario de Pontevedra- Montecelo
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Salamanca, Spain
- H. Clínico de Salamanca
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Santiago de Compostela, Spain
- Hospital Clinico Universitario
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Valencia, Spain
- Hospital Universitario La Fe
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men or women
- Age 18 to 70 years
- Acute vertigo attack due to vestibular disorder
Exclusion Criteria:
- Signs of brain, brainstem and/or cerebellar dysfunction
- Concomitant central neurological disorder
- Psychogenic vertigo
- Use of ototoxic drugs causing vertigo or dizziness within the last month
- Use of anti-dizziness medications from the onset of symptoms, except if the dosage had been stable for at least 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Placebo
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single dose
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Experimental: V0251
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single dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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"Vertigo Symptoms Score" (VSS) rated by patient using VAS
Time Frame: 30 min
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30 min
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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"Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS
Time Frame: 30 min, 2 hours and 4 hours post dose
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30 min, 2 hours and 4 hours post dose
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Number of patients with Adverse Events as a measure of safety and tolerability
Time Frame: 30 min, 2 hours and 4 hours post dose
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30 min, 2 hours and 4 hours post dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
April 11, 2012
First Submitted That Met QC Criteria
April 20, 2012
First Posted (Estimate)
April 24, 2012
Study Record Updates
Last Update Posted (Estimate)
October 30, 2014
Last Update Submitted That Met QC Criteria
October 29, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V0251 IV 202 4A
- 2011-003412-23 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.