Completed

NCT Number: NCT01583738

Effect of V0251 in Acute Vertigo

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

Completed

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Key information

Conditions

Acute Vertigo

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fakultni Nemocnice Hradec Králové, Hradec Králové, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V0251

Drug

single dose

Placebo

Drug

single dose

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

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Apr 24, 2012
Registry last updated: Oct 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.