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Effect of V0251 in Acute Vertigo

This study has been completed.
Information provided by (Responsible Party):
Pierre Fabre Medicament Identifier:
First received: April 11, 2012
Last updated: October 29, 2014
Last verified: October 2014
Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.

Condition Intervention Phase
Acute Vertigo
Drug: V0251
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • "Vertigo Symptoms Score" (VSS) rated by patient using VAS [ Time Frame: 30 min ]

Secondary Outcome Measures:
  • "Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS [ Time Frame: 30 min, 2 hours and 4 hours post dose ]
  • Number of patients with Adverse Events as a measure of safety and tolerability [ Time Frame: 30 min, 2 hours and 4 hours post dose ]

Enrollment: 132
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V0251 Drug: V0251
single dose
Placebo Comparator: Placebo Drug: placebo
single dose


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01583738

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
Faculty Hospital Motol
Praha, Czech Republic
Thomayer's Teaching Hospital
Praha, Czech Republic
Strepomrauska Nemocaicni a. S.
Prostejov, Czech Republic
CHI Elbeuf-Louviers-Val de Reuil
Elbeuf, France
Hôpital Nord
Marseille, France
CHU de Rouen, Hopital Charles Nicolle
Rouen, France
Hôpital Nord
St Etienne, France
Hopital Purpan
Toulouse, France
Universitätsklinikum Aachen
Aachen, Germany
HELIOS Klinikum Berlin-Buch
Berlin, Germany
Park - Klinik Weissensee
Berlin, Germany
Allgemeines Krankenhaus Celle
Celle, Germany
Universitätsklinikum Essen
Essen, Germany
Frankfurt Am Main, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, Germany
University Hospital Mannheim
Mannheim, Germany
Universitätsklinikum München
München, Germany
Semmelweis Egyetem Neurológiai Klinika
Budapest, Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
Debrecen, Hungary
Petz Aladár Megyei Oktató Kórház
Gyor, Hungary
Kaposi Mór Megyei Oktató Kórhaz
Kaposvar, Hungary
Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, Hungary
Kanizsai Dorottya Kórház
Nagykanizsa, Hungary
Pécsi Tudományegyetem Általános Orvostudományi Kar
Pecs, Hungary
Soproni Erzsébet Oktató Kórház
Sopron, Hungary
Markusovszky County Hospital
Szombathely, Hungary
Complejo H.Universitario de Badajoz
Badajoz, Spain
Hospital de Poniente
El Ejido, Spain
Hospital Universitario de Getafe
GETAFE -Madrid, Spain
Hospital Comarcal San Agustin
Linares, Spain
Hospital Gregorio Marañón
Madrid, Spain
Clinica Universitaria de Navarra
Pamplona, Spain
Complejo Hospitalario de Pontevedra- Montecelo
Pontevedra, Spain
H. Clínico de Salamanca
Salamanca, Spain
Hospital Clinico Universitario
Santiago de Compostela, Spain
Hospital Universitario La Fe
Valencia, Spain
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

Responsible Party: Pierre Fabre Medicament Identifier: NCT01583738     History of Changes
Other Study ID Numbers: V0251 IV 202 4A
2011-003412-23 ( EudraCT Number )
Study First Received: April 11, 2012
Last Updated: October 29, 2014

Additional relevant MeSH terms:
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders processed this record on April 21, 2017