Effect of V0251 in Acute Vertigo

Pierre Fabre

Status and phase: Completed; Phase 2

Conditions: Acute Vertigo

Treatments: Drug: placebo; Drug: V0251

Study type: Interventional

Funder types: Industry

Identifiers

NCT01583738

V0251 IV 202 4A

2011-003412-23 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 132 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

V0251

Experimental group

Treatment:

Drug: V0251

Placebo

Placebo Comparator group

Treatment:

Drug: placebo