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: May 29, 2013
Last verified: April 2012
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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 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
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 June 18, 2013