Effect of V0251 in Acute Vertigo
- Registration Number
- NCT01583738
- Lead Sponsor
- Pierre Fabre Medicament
- Brief Summary
Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V0251 V0251 - Placebo placebo -
- Primary Outcome Measures
Name Time Method "Vertigo Symptoms Score" (VSS) rated by patient using VAS 30 min
- Secondary Outcome Measures
Name Time Method Number of patients with Adverse Events as a measure of safety and tolerability 30 min, 2 hours and 4 hours post dose "Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS 30 min, 2 hours and 4 hours post dose
Trial Locations
- Locations (39)
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
CHI Elbeuf-Louviers-Val de Reuil
🇫🇷Elbeuf, France
Hôpital Nord
🇫🇷St Etienne, France
CHU de Rouen, Hopital Charles Nicolle
🇫🇷Rouen, France
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