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Effect of V0251 in Acute Vertigo

This study is currently recruiting participants.
Verified April 2012 by Pierre Fabre Medicament
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01583738
First received: April 11, 2012
Last updated: October 5, 2012
Last verified: April 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Number of patients with Adverse Events as a measure of safety and tolerability [ Time Frame: 30 min, 2 hours and 4 hours post dose ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583738

Contacts
Contact: Institut de Recherche Pierre Fabre +33 5 34 50 61 90 eric.garrigue@pierre-fabre.com

Locations
Czech Republic
Fakultni Nemocnice Hradec Králové Not yet recruiting
Hradec Králové, Czech Republic
Regional Hospital Kladno Not yet recruiting
Kladno, Czech Republic
Faculty Hospital Ostrava Not yet recruiting
Ostrava, Czech Republic
Faculty Hospital Královské Vinohrady Not yet recruiting
Praha, Czech Republic
Faculty Hospital Motol Not yet recruiting
Praha, Czech Republic
Thomayer's Teaching Hospital Not yet recruiting
Praha, Czech Republic
Strepomrauska Nemocaicni a. S. Not yet recruiting
Prostejov, Czech Republic
France
CHU Côte de Nacre Recruiting
Caen, France
Hôpital Nord Recruiting
Marseille, France
CHU de Rouen, Hopital Charles Nicolle Recruiting
Rouen, France
Hôpital Nord Recruiting
St Etienne, France
Hopital Purpan Recruiting
Toulouse, France
Contact: FRAYSSE            
Germany
Universitätsklinikum Aachen Not yet recruiting
Aachen, Germany
HELIOS Klinikum Berlin-Buch Not yet recruiting
Berlin, Germany
Park - Klinik Weissensee Not yet recruiting
Berlin, Germany
Allgemeines Krankenhaus Celle Not yet recruiting
Celle, Germany
Universitätsklinikum Essen Not yet recruiting
Essen, Germany
Goethe-University Not yet recruiting
Frankfurt Am Main, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck Not yet recruiting
Lübeck, Germany
University Hospital Mannheim Not yet recruiting
Mannheim, Germany
Universitätsklinikum München Not yet recruiting
München, Germany
Universitätsklinikum Regensburg Not yet recruiting
Regensburg, Germany
Spain
Complejo H.Universitario de Badajoz Not yet recruiting
Badajoz, Spain
Hospital de Poniente Not yet recruiting
El Ejido, Spain
Hospital Universitario de Getafe Not yet recruiting
GETAFE -Madrid, Spain
Hospital de Cabueñes Not yet recruiting
Gijón, Spain
Hospital Virgen de las Nieves Not yet recruiting
Granada, Spain
Hospital Comarcal San Agustin Not yet recruiting
Linares, Spain
Hospital Gregorio Marañón Recruiting
Madrid, Spain
Clinica Universitaria de Navarra Not yet recruiting
Pamplona, Spain
Complejo Hospitalario de Pontevedra- Montecelo Not yet recruiting
Pontevedra, Spain
H. Clínico de Salamanca Recruiting
Salamanca, Spain
Hospital Clinico Universitario Not yet recruiting
Santiago de Compostela, Spain
Hospital Universitario La Fe Not yet recruiting
Valencia, Spain
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01583738     History of Changes
Other Study ID Numbers: V0251 IV 202 4A, 2011-003412-23
Study First Received: April 11, 2012
Last Updated: October 5, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
 Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders

ClinicalTrials.gov processed this record on May 16, 2013