Acute Vertigo Clinical Trial
Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.
| Status | Completed |
| Enrollment | 132 |
| Est. completion date | April 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Pierre Fabre Medicament |
Czech Republic, France, Germany, Hungary, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | "Vertigo Symptoms Score" (VSS) rated by patient using VAS | 30 min | No | |
| Secondary | "Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS | 30 min, 2 hours and 4 hours post dose | No | |
| Secondary | Number of patients with Adverse Events as a measure of safety and tolerability | 30 min, 2 hours and 4 hours post dose | No |