Effect of V0251 in Acute Vertigo

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01583738
First received: April 11, 2012
Last updated: May 29, 2013
Last verified: April 2012
  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:


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 ]

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583738

Locations
Czech Republic
Fakultni Nemocnice Hradec Králové
Hradec Králové, Czech Republic
Regional Hospital Kladno
Kladno, Czech Republic
Faculty Hospital Ostrava
Ostrava, Czech Republic
Faculty Hospital Motol
Praha, Czech Republic
Faculty Hospital Královské Vinohrady
Praha, Czech Republic
Thomayer's Teaching Hospital
Praha, Czech Republic
Strepomrauska Nemocaicni a. S.
Prostejov, Czech Republic
France
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
Germany
Universitätsklinikum Aachen
Aachen, Germany
HELIOS Klinikum Berlin-Buch
Berlin, Germany
Park - Klinik Weissensee
Berlin, Germany
Allgemeines Krankenhaus Celle
Celle, Germany
Universitätsklinikum Essen
Essen, Germany
Goethe-University
Frankfurt Am Main, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, Germany
University Hospital Mannheim
Mannheim, Germany
Universitätsklinikum München
München, Germany
Hungary
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
Spain
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

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: May 29, 2013
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 August 18, 2014