Acute VertigoPhase 2NCT01583738
Effect of V0251 in Acute Vertigo
A Phase 2 study testing V0251 in people with Acute Vertigo, run by Pierre Fabre Medicament at 40 sites in 5 countries.
Trial summary
Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Vertigo
- What is being tested?
- V0251
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 40 sitesin 5 countries
- Study dates
- Apr 2012to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women
- Age 18 to 70 years
- Acute vertigo attack due to vestibular disorder
Who cannot join
- 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 locations and contacts
40 sites in 5 countries.
40 sites in 5 countries
Spain10 sites
Complejo H.Universitario de Badajoz
Badajoz
Hospital de Poniente
El Ejido
Hospital Universitario de Getafe
Getafe -Madrid
Hospital Comarcal San Agustin
Linares
Hospital Gregorio Marañón
Madrid
Clinica Universitaria de Navarra
Pamplona
Complejo Hospitalario de Pontevedra- Montecelo
Pontevedra
H. Clínico de Salamanca
Salamanca
Hospital Clinico Universitario
Santiago de Compostela
Hospital Universitario La Fe
Valencia
Germany9 sites
Universitätsklinikum Aachen
Aachen
HELIOS Klinikum Berlin-Buch
Berlin
Park - Klinik Weissensee
Berlin
Allgemeines Krankenhaus Celle
Celle
Universitätsklinikum Essen
Essen
Goethe-University
Frankfurt am Main
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck
University Hospital Mannheim
Mannheim
Universitätsklinikum München
München
Hungary9 sites
Semmelweis Egyetem Neurológiai Klinika
Budapest
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
Debrecen
Petz Aladár Megyei Oktató Kórház
Győr
Kaposi Mór Megyei Oktató Kórhaz
Kaposvár
Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc
Kanizsai Dorottya Kórház
Nagykanizsa
Pécsi Tudományegyetem Általános Orvostudományi Kar
Pécs
Soproni Erzsébet Oktató Kórház
Sopron
Markusovszky County Hospital
Szombathely
Czechia7 sites
Fakultni Nemocnice Hradec Králové
Hradec Králové
Regional Hospital Kladno
Kladno
Faculty Hospital Ostrava
Ostrava
Faculty Hospital Královské Vinohrady
Prague
Faculty Hospital Motol
Prague
Thomayer's Teaching Hospital
Prague
Strepomrauska Nemocaicni a. S.
Prostějov
France5 sites
CHI Elbeuf-Louviers-Val de Reuil
Elbeuf
Hôpital Nord
Marseille
CHU de Rouen, Hopital Charles Nicolle
Rouen
Hôpital Nord
Saint-Etienne
Hopital Purpan
Toulouse
About this study
Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.
- Conditions
- Acute Vertigo
- Being tested
- V0251, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V0251Drug
single dose
placeboDrug
single dose
| Study group | Role | What they receive |
|---|---|---|
| V0251 | Experimental | Not described Receives: Drug: V0251 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Vertigo Symptoms Score" (VSS) rated by patient using VAS
Measured: 30 min
Secondary outcomes (2)
"Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS
Measured: 30 min, 2 hours and 4 hours post dose
Number of patients with Adverse Events as a measure of safety and tolerability
Measured: 30 min, 2 hours and 4 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583738
- Sponsor's protocol ID
- V0251 IV 202 4A
- Other IDs
- 2011-003412-23
- Status last verified
- Oct 2014
- First submitted
- 11 Apr 2012
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of V0251 in Acute Vertigo
- ClinicalTrials.gov ID
- NCT01583738
- Acronym / sponsor ID
- V0251 IV 202 4A
- Conditions
- Acute Vertigo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V0251 | Experimental | Drug: V0251 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women
- Age 18 to 70 years
- Acute vertigo attack due to vestibular disorder
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V0251single dose | Drug | V0251 |
| placebosingle dose | Drug | Placebo |
Primary outcome
"Vertigo Symptoms Score" (VSS) rated by patient using VAS
Time frame: 30 min
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
Related trials for Acute Vertigo
Not yet recruitingPhase 2/3
Efficacy and Safety of Rimegepant for Acute Dizziness
Dizziness
Not yet recruitingObservational study
Chinese Real-world Study of Treatment of Vestibular Migraine
Vestibular Migraine, Dizziness
Not yet recruiting
Quantitative Eye Movement Measurements in Patients with Acute Vestibular Syndrome
Acute Vestibular Syndrome, Vertigo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V0251 in people with Acute Vertigo, run by Pierre Fabre Medicament at 40 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Spain, Germany, Hungary, Czechia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Vertigo Symptoms Score" (VSS) rated by patient using VAS (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2014.