Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

132

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Apr 2012

Shorter than P25 for phase_2

Geographic Reach

5 countries

40 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

April 1, 2012

Completed

10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed

13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed

Last Updated

October 30, 2014

Status Verified

October 1, 2014

Enrollment Period

1 year

First QC Date

April 11, 2012

Last Update Submit

October 29, 2014

Conditions

Acute Vertigo

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

"Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS
30 min, 2 hours and 4 hours post dose
Number of patients with Adverse Events as a measure of safety and tolerability
30 min, 2 hours and 4 hours post dose

Study Arms (2)

V0251

EXPERIMENTAL

Drug: V0251

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

V0251DRUG

single dose

V0251

placeboDRUG

single dose

Placebo

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Men or women
Age 18 to 70 years
Acute vertigo attack due to vestibular disorder

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pierre Fabre Medicamentlead

Study Sites (40)

Fakultni Nemocnice Hradec Králové

Hradec Králové, Czechia

Location

Regional Hospital Kladno

Kladno, Czechia

Location

Faculty Hospital Ostrava

Ostrava, Czechia

Location

Faculty Hospital Královské Vinohrady

Prague, Czechia

Location

Faculty Hospital Motol

Prague, Czechia

Location

Thomayer's Teaching Hospital

Prague, Czechia

Location

Strepomrauska Nemocaicni a. S.

Prostějov, Czechia

Location

CHI Elbeuf-Louviers-Val de Reuil

Elbeuf, France

Location

Hôpital Nord

Marseille, France

Location

CHU de Rouen, Hopital Charles Nicolle

Rouen, France

Location

Hôpital Nord

Saint-Etienne, France

Location

Hopital Purpan

Toulouse, France

Location

Universitätsklinikum Aachen

Aachen, Germany

Location

HELIOS Klinikum Berlin-Buch

Berlin, Germany

Location

Park - Klinik Weissensee

Berlin, Germany

Location

Allgemeines Krankenhaus Celle

Celle, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Goethe-University

Frankfurt am Main, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Germany

Location

University Hospital Mannheim

Mannheim, Germany

Location

Universitätsklinikum München

München, Germany

Location

Semmelweis Egyetem Neurológiai Klinika

Budapest, Hungary

Location

Debreceni Egyetem Orvos- és Egészségtudományi Centrum

Debrecen, Hungary

Location

Petz Aladár Megyei Oktató Kórház

Győr, Hungary

Location

Kaposi Mór Megyei Oktató Kórhaz

Kaposvár, Hungary

Location

Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház

Miskolc, Hungary

Location

Kanizsai Dorottya Kórház

Nagykanizsa, Hungary

Location

Pécsi Tudományegyetem Általános Orvostudományi Kar

Pécs, Hungary

Location

Soproni Erzsébet Oktató Kórház

Sopron, Hungary

Location

Markusovszky County Hospital

Szombathely, Hungary

Location

Complejo H.Universitario de Badajoz

Badajoz, Spain

Location

Hospital de Poniente

El Ejido, Spain

Location

Hospital Universitario de Getafe

Getafe -Madrid, Spain

Location

Hospital Comarcal San Agustin

Linares, Spain

Location

Hospital Gregorio Marañón

Madrid, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

Complejo Hospitalario de Pontevedra- Montecelo

Pontevedra, Spain

Location

H. Clínico de Salamanca

Salamanca, Spain

Location

Hospital Clinico Universitario

Santiago de Compostela, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 24, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 30, 2014

Record last verified: 2014-10

Locations

CZ(7)DE(9)HU(9)FR(5)ES(10)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

V0251

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (40)

Study Design

Study Record Dates

Locations