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Effect of V0251 in Acute Vertigo

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ClinicalTrials.gov Identifier: NCT01583738
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

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

Condition or disease Intervention/treatment Phase
Acute Vertigo Drug: V0251 Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: V0251 Drug: V0251
single dose
Placebo Comparator: Placebo Drug: placebo
single dose


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 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
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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01583738     History of Changes
Other Study ID Numbers: V0251 IV 202 4A
2011-003412-23 ( EudraCT Number )
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014

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