Effect of V0251 in Acute Vertigo

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01583738

Enrollment

132

Registered

2012-04-24

Start date

2012-04-30

Completion date

2013-04-30

Last updated

2014-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Vertigo

Brief summary

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

Interventions

DRUGV0251

single dose

DRUGplacebo

single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Vertigo Symptoms Score (VSS) rated by patient using VAS	30 min

Secondary

Measure	Time frame
Concomitant and Vegetative Symptoms Score (CVSS) rated by patients using VAS	30 min, 2 hours and 4 hours post dose
Number of patients with Adverse Events as a measure of safety and tolerability	30 min, 2 hours and 4 hours post dose

Countries

Czechia, France, Germany, Hungary, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026