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Effect of V0251 in Acute Vertigo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583738
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : October 30, 2014
Information provided by (Responsible Party):
Pierre Fabre Medicament

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

Condition or disease Intervention/treatment Phase
Acute Vertigo Drug: V0251 Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: V0251 Drug: V0251
single dose

Placebo Comparator: Placebo Drug: placebo
single dose

Primary Outcome Measures :
  1. "Vertigo Symptoms Score" (VSS) rated by patient using VAS [ Time Frame: 30 min ]

Secondary Outcome Measures :
  1. "Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS [ Time Frame: 30 min, 2 hours and 4 hours post dose ]
  2. Number of patients with Adverse Events as a measure of safety and tolerability [ Time Frame: 30 min, 2 hours and 4 hours post dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01583738

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Sponsors and Collaborators
Pierre Fabre Medicament
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Responsible Party: Pierre Fabre Medicament Identifier: NCT01583738    
Other Study ID Numbers: V0251 IV 202 4A
2011-003412-23 ( EudraCT Number )
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Sensation Disorders