Clinical trial NCT01583738: Effect of V0251 in Acute Vertigo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Vertigo
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2012-04-24
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: "Vertigo Symptoms Score" (VSS) rated by patient using VAS
timeFrame: 30 min
Secondary outcomes:
measure: "Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS
timeFrame: 30 min, 2 hours and 4 hours post dose
measure: Number of patients with Adverse Events as a measure of safety and tolerability
timeFrame: 30 min, 2 hours and 4 hours post dose
Other outcomes:
Locations:
city: Hradec Králové
country: Czech Republic
facility: Fakultni Nemocnice Hradec Králové
city: Kladno
country: Czech Republic
facility: Regional Hospital Kladno
city: Ostrava
country: Czech Republic
facility: Faculty Hospital Ostrava
city: Praha
country: Czech Republic
facility: Faculty Hospital Královské Vinohrady
city: Praha
country: Czech Republic
facility: Faculty Hospital Motol
city: Praha
country: Czech Republic
facility: Thomayer's Teaching Hospital
city: Prostejov
country: Czech Republic
facility: Strepomrauska Nemocaicni a. S.
city: Elbeuf
country: France
facility: CHI Elbeuf-Louviers-Val de Reuil
city: Marseille
country: France
facility: Hôpital Nord
city: Rouen
country: France
facility: CHU de Rouen, Hopital Charles Nicolle
city: St Etienne
country: France
facility: Hôpital Nord
city: Toulouse
country: France
facility: Hopital Purpan
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
city: Berlin
country: Germany
facility: Park - Klinik Weissensee
city: Celle
country: Germany
facility: Allgemeines Krankenhaus Celle
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt Am Main
country: Germany
facility: Goethe-University
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck
city: Mannheim
country: Germany
facility: University Hospital Mannheim
city: München
country: Germany
facility: Universitätsklinikum München
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Neurológiai Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum
city: Gyor
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
city: Kaposvar
country: Hungary
facility: Kaposi Mór Megyei Oktató Kórhaz
city: Miskolc
country: Hungary
facility: Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
city: Nagykanizsa
country: Hungary
facility: Kanizsai Dorottya Kórház
city: Pecs
country: Hungary
facility: Pécsi Tudományegyetem Általános Orvostudományi Kar
city: Sopron
country: Hungary
facility: Soproni Erzsébet Oktató Kórház
city: Szombathely
country: Hungary
facility: Markusovszky County Hospital
city: Badajoz
country: Spain
facility: Complejo H.Universitario de Badajoz
city: El Ejido
country: Spain
facility: Hospital de Poniente
city: GETAFE -Madrid
country: Spain
facility: Hospital Universitario de Getafe
city: Linares
country: Spain
facility: Hospital Comarcal San Agustin
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra- Montecelo
city: Salamanca
country: Spain
facility: H. Clínico de Salamanca
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
References: