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Effect of V0251 in Acute Vertigo
This study has been completed.
Sponsor:
Pierre Fabre Medicament
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01583738
First received: April 11, 2012
Last updated: October 29, 2014
Last verified: October 2014
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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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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 ]
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 ]
- Number of patients with Adverse Events as a measure of safety and tolerability [ Time Frame: 30 min, 2 hours and 4 hours post dose ]
| 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 (Adult, Senior) |
| 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
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
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 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
| 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 ) |
| Study First Received: | April 11, 2012 |
| Last Updated: | October 29, 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 |
ClinicalTrials.gov processed this record on September 21, 2017