Effect of V0251 in Acute Vertigo

Phase 2

Completed

• Conditions: Acute Vertigo
• Interventions: Drug: V0251; Drug: placebo

• Registration Number: NCT01583738
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-24
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-29
• Last Update Posted: 2014-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V0251	V0251	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
"Vertigo Symptoms Score" (VSS) rated by patient using VAS	30 min

Secondary Outcome Measures

Name	Time	Method
Number of patients with Adverse Events as a measure of safety and tolerability	30 min, 2 hours and 4 hours post dose
"Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS	30 min, 2 hours and 4 hours post dose

Trial Locations

Locations (39)

Pécsi Tudományegyetem Általános Orvostudományi Kar; 🇭🇺 Pecs, Hungary

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Petz Aladár Megyei Oktató Kórház; 🇭🇺 Gyor, Hungary

Kaposi Mór Megyei Oktató Kórhaz; 🇭🇺 Kaposvar, Hungary

Thomayer's Teaching Hospital; 🇨🇿 Praha, Czech Republic

Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház; 🇭🇺 Miskolc, Hungary

Faculty Hospital Motol; 🇨🇿 Praha, Czech Republic

Fakultni Nemocnice Hradec Králové; 🇨🇿 Hradec Králové, Czech Republic

Regional Hospital Kladno; 🇨🇿 Kladno, Czech Republic

Faculty Hospital Ostrava; 🇨🇿 Ostrava, Czech Republic

Faculty Hospital Královské Vinohrady; 🇨🇿 Praha, Czech Republic

Strepomrauska Nemocaicni a. S.; 🇨🇿 Prostejov, Czech Republic

CHI Elbeuf-Louviers-Val de Reuil; 🇫🇷 Elbeuf, France

Hôpital Nord; 🇫🇷 St Etienne, France

Hopital Purpan; 🇫🇷 Toulouse, France

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

CHU de Rouen, Hopital Charles Nicolle; 🇫🇷 Rouen, France

Park - Klinik Weissensee; 🇩🇪 Berlin, Germany

HELIOS Klinikum Berlin-Buch; 🇩🇪 Berlin, Germany

Allgemeines Krankenhaus Celle; 🇩🇪 Celle, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Semmelweis Egyetem Neurológiai Klinika; 🇭🇺 Budapest, Hungary

Goethe-University; 🇩🇪 Frankfurt Am Main, Germany

Universitätsklinikum Schleswig-Holstein Campus Lübeck; 🇩🇪 Lübeck, Germany

University Hospital Mannheim; 🇩🇪 Mannheim, Germany

Universitätsklinikum München; 🇩🇪 München, Germany

Kanizsai Dorottya Kórház; 🇭🇺 Nagykanizsa, Hungary

Debreceni Egyetem Orvos- és Egészségtudományi Centrum; 🇭🇺 Debrecen, Hungary

Soproni Erzsébet Oktató Kórház; 🇭🇺 Sopron, Hungary

Complejo H.Universitario de Badajoz; 🇪🇸 Badajoz, Spain

Hospital de Poniente; 🇪🇸 El Ejido, Spain

Markusovszky County Hospital; 🇭🇺 Szombathely, Hungary

Hospital Universitario de Getafe; 🇪🇸 GETAFE -Madrid, Spain

Hospital Comarcal San Agustin; 🇪🇸 Linares, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Clinica Universitaria de Navarra; 🇪🇸 Pamplona, Spain

Hospital Clinico Universitario; 🇪🇸 Santiago de Compostela, Spain

Complejo Hospitalario de Pontevedra- Montecelo; 🇪🇸 Pontevedra, Spain

H. Clínico de Salamanca; 🇪🇸 Salamanca, Spain