Effect of V0251 in Acute Vertigo

Phase 2CompletedNCT01583738

Pierre Fabre Medicament132 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

132

Conditions

Acute Vertigo

Interventions

V0251DRUG

single dose

placeboDRUG

single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (40)

Outcomes

Primary Outcomes

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

Time frame: 30 min

Secondary Outcomes

"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

Data from ClinicalTrials.gov

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Fakultni Nemocnice Hradec Králové

Hradec Králové, Czechia

Regional Hospital Kladno

Kladno, Czechia

Faculty Hospital Ostrava

Ostrava, Czechia

Faculty Hospital Královské Vinohrady

Prague, Czechia

Faculty Hospital Motol

Prague, Czechia

Thomayer's Teaching Hospital

Prague, Czechia

Strepomrauska Nemocaicni a. S.

Prostějov, Czechia

CHI Elbeuf-Louviers-Val de Reuil

Elbeuf, France

Hôpital Nord

Marseille, France

CHU de Rouen, Hopital Charles Nicolle

Rouen, France

...and 30 more locations