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Effect of V0251 in Acute Vertigo

Primary Purpose

Acute Vertigo

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
V0251
placebo
Sponsored by
Pierre Fabre Medicament
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Vertigo

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fakultni Nemocnice Hradec Králové
  • Regional Hospital Kladno
  • Faculty Hospital Ostrava
  • Faculty Hospital Královské Vinohrady
  • Faculty Hospital Motol
  • Thomayer's Teaching Hospital
  • Strepomrauska Nemocaicni a. S.
  • CHI Elbeuf-Louviers-Val de Reuil
  • Hôpital Nord
  • CHU de Rouen, Hopital Charles Nicolle
  • Hôpital Nord
  • Hopital Purpan
  • Universitätsklinikum Aachen
  • HELIOS Klinikum Berlin-Buch
  • Park - Klinik Weissensee
  • Allgemeines Krankenhaus Celle
  • Universitätsklinikum Essen
  • Goethe-University
  • Universitätsklinikum Schleswig-Holstein Campus Lübeck
  • University Hospital Mannheim
  • Universitätsklinikum München
  • Semmelweis Egyetem Neurológiai Klinika
  • Debreceni Egyetem Orvos- és Egészségtudományi Centrum
  • Petz Aladár Megyei Oktató Kórház
  • Kaposi Mór Megyei Oktató Kórhaz
  • Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
  • Kanizsai Dorottya Kórház
  • Pécsi Tudományegyetem Általános Orvostudományi Kar
  • Soproni Erzsébet Oktató Kórház
  • Markusovszky County Hospital
  • Complejo H.Universitario de Badajoz
  • Hospital de Poniente
  • Hospital Universitario de Getafe
  • Hospital Comarcal San Agustin
  • Hospital Gregorio Marañón
  • Clinica Universitaria de Navarra
  • Complejo Hospitalario de Pontevedra- Montecelo
  • H. Clínico de Salamanca
  • Hospital Clinico Universitario
  • Hospital Universitario La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

V0251

Placebo

Arm Description

Outcomes

Primary Outcome Measures

"Vertigo Symptoms Score" (VSS) rated by patient using VAS

Secondary Outcome Measures

"Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS
Number of patients with Adverse Events as a measure of safety and tolerability

Full Information

First Posted
April 11, 2012
Last Updated
October 29, 2014
Sponsor
Pierre Fabre Medicament
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1. Study Identification

Unique Protocol Identification Number
NCT01583738
Brief Title
Effect of V0251 in Acute Vertigo
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V0251
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
V0251
Intervention Description
single dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
single dose
Primary Outcome Measure Information:
Title
"Vertigo Symptoms Score" (VSS) rated by patient using VAS
Time Frame
30 min
Secondary Outcome Measure Information:
Title
"Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS
Time Frame
30 min, 2 hours and 4 hours post dose
Title
Number of patients with Adverse Events as a measure of safety and tolerability
Time Frame
30 min, 2 hours and 4 hours post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fakultni Nemocnice Hradec Králové
City
Hradec Králové
Country
Czech Republic
Facility Name
Regional Hospital Kladno
City
Kladno
Country
Czech Republic
Facility Name
Faculty Hospital Ostrava
City
Ostrava
Country
Czech Republic
Facility Name
Faculty Hospital Královské Vinohrady
City
Praha
Country
Czech Republic
Facility Name
Faculty Hospital Motol
City
Praha
Country
Czech Republic
Facility Name
Thomayer's Teaching Hospital
City
Praha
Country
Czech Republic
Facility Name
Strepomrauska Nemocaicni a. S.
City
Prostejov
Country
Czech Republic
Facility Name
CHI Elbeuf-Louviers-Val de Reuil
City
Elbeuf
Country
France
Facility Name
Hôpital Nord
City
Marseille
Country
France
Facility Name
CHU de Rouen, Hopital Charles Nicolle
City
Rouen
Country
France
Facility Name
Hôpital Nord
City
St Etienne
Country
France
Facility Name
Hopital Purpan
City
Toulouse
Country
France
Facility Name
Universitätsklinikum Aachen
City
Aachen
Country
Germany
Facility Name
HELIOS Klinikum Berlin-Buch
City
Berlin
Country
Germany
Facility Name
Park - Klinik Weissensee
City
Berlin
Country
Germany
Facility Name
Allgemeines Krankenhaus Celle
City
Celle
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
Goethe-University
City
Frankfurt Am Main
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein Campus Lübeck
City
Lübeck
Country
Germany
Facility Name
University Hospital Mannheim
City
Mannheim
Country
Germany
Facility Name
Universitätsklinikum München
City
München
Country
Germany
Facility Name
Semmelweis Egyetem Neurológiai Klinika
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
City
Debrecen
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház
City
Gyor
Country
Hungary
Facility Name
Kaposi Mór Megyei Oktató Kórhaz
City
Kaposvar
Country
Hungary
Facility Name
Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
City
Miskolc
Country
Hungary
Facility Name
Kanizsai Dorottya Kórház
City
Nagykanizsa
Country
Hungary
Facility Name
Pécsi Tudományegyetem Általános Orvostudományi Kar
City
Pecs
Country
Hungary
Facility Name
Soproni Erzsébet Oktató Kórház
City
Sopron
Country
Hungary
Facility Name
Markusovszky County Hospital
City
Szombathely
Country
Hungary
Facility Name
Complejo H.Universitario de Badajoz
City
Badajoz
Country
Spain
Facility Name
Hospital de Poniente
City
El Ejido
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
GETAFE -Madrid
Country
Spain
Facility Name
Hospital Comarcal San Agustin
City
Linares
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
Country
Spain
Facility Name
Complejo Hospitalario de Pontevedra- Montecelo
City
Pontevedra
Country
Spain
Facility Name
H. Clínico de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Clinico Universitario
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

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Effect of V0251 in Acute Vertigo

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