Vestibular MigrainePhase 2/3NCT02447991
Rizatriptan for Episodic Dizziness in Vestibular Migraine
A Phase 2/3 study testing Rizatriptan in people with Vestibular Migraine and Migrainous Vertigo, run by Robert W. Baloh at 3 sites in United States.
Trial summary
Suffering from dizzy spells and migraine headaches? Vestibular Migraine (VM), a newly recognized type of migraine that causes bouts of dizziness. University of California, Los Angeles (UCLA) and The Mayo Clinic is seeking people with VM to participate in a research study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vestibular Migraine, Migrainous Vertigo
- What is being tested?
- Rizatriptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2014to 31 Jul 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are between the ages of 18 \& 65
- Have a history of vestibular migraine
- Are able to maintain a vestibular symptom diary
- History that fulfills all criteria for VM as defined in Table 1, except that attacks must last at least 2 hours.
- At least 5 episodes
- A current or past history of migraine without aura or migraine with aura
Show all 19Show fewer
- Vestibular symptoms of moderate or severe intensity lasting at least 2 hours
- 50% of episodes are associated with at least one of the following:
- Headache with at least 2 of:
- unilateral location
- pulsating quality
- moderate or severe intensity,
- aggravation by routine physical activity
- Experience photophobia and phonophobia
- Experience visual aura
- Episodes must have a spontaneous onset and resolution without associated hearing loss or interictal neurotologic deficits.
- Other causes of vestibular symptoms ruled out by appropriate clinical investigations.
- Current medication list compatible with Concomitant Medications below.
- Able to maintain a Vestibular Symptom Diary and complete all other study procedures.
Who cannot join
- Ménière's disease by The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) criteria60.
- Migraine with brainstem aura (formerly basilar-type migraine) by the International Classification of Headache Disorders (ICHD-3) criteria.14
- Ischemic heart disease, coronary artery vasospasm, uncontrolled hypertension.
- History of stroke or transient ischemic attack.
- History of using rizatriptan specifically to treat vestibular attacks.
- History of adverse response to triptans or intolerance to lactose.
- Women who are pregnant or breastfeeding.
- Unable or unwilling to comply with study requirements for any reason.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California, Los Angeles
Los Angeles, California, 90095
ICAHN School of Medicine at Mount Sinai
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Phase II/III Trial on Rizatriptan for Vestibular Migraine
Suffering from dizzy spells and migraine headaches?
Vestibular Migraine (VM), a newly recognized type of migraine that causes bouts of dizziness.
Read more
University of California, Los Angeles (UCLA) and The Mayo Clinic is seeking people with VM to participate in a research study. The purpose of this study is to look at the natural history of VM and learn more about common symptoms. Investigators also want to learn the effects, both positive and negative, of the commonly used migraine drug, rizatriptan, when it is used for spells of dizziness in people with VM.
Patients may be eligible to participate if:
- Patients are between the ages of 18 \& 65
- Patients have a history of vestibular migraine
- Patients are able to maintain a vestibular symptom diary
The study includes 3 visits with compensation. All participants must complete questionnaires on dizziness, headache symptoms, general health and well-being, mental health, and a questionnaire on patient's satisfaction with study medication.
Read the detailed description
The primary Specific Aim is to conduct the first successful controlled study of a treatment for Vestibular Migraine. The investigators hypothesize that rizatriptan will be superior to a look alike inactive capsule for:
1a. Reducing the severity and duration of vertigo attacks in patients with Vestibular Migraine,
1b. Reducing the severity of symptoms commonly associated with vertigo attacks in patients with Vestibular Migraine (e.g., nausea, vomiting, motion sensitivity, gait disturbance, headache, light and sound sensitivity), and
1c. Improving treatment satisfaction and health-related quality of life in patients with Vestibular Migraine, and that
1d. Rizatriptan will be well tolerated by patients with Vestibular Migraine.
- Conditions
- Vestibular Migraine, Migrainous Vertigo
- Being tested
- Rizatriptan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RizatriptanDrug
Also called Maxalt
During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study.
PlaceboDrug
Also called Sugar Pill
During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | During the Treatment Phase, three placebo capsules will be administered to each subject. One capsule will be taken during one acute episode, until three episodes are treated with the study drug. Receives: Drug: Placebo |
| Rizatriptan | Experimental | During the Treatment Phase, three Rizatriptan capsules will be administered to each subject. One capsule will be taken during one acute episode, until three episodes are treated with the study drug. Receives: Drug: Rizatriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild
Episodes in which a reduction in symptom severity from moderate/severe (rating 2/3) at time of taking study medication to none/mild rating (0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms (vertigo and unsteadiness/dizziness) wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 1 hour after taking study medication
Episodes With Symptoms of Unsteadiness/Dizziness Reduced From Moderate/Severe to None/Mild
Episodes of unsteadiness/dizziness in which a reduction in symptom severity from moderate/severe (rating 2/3) to none/mild rating (0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms (vertigo and unsteadiness/dizziness) wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 1 hour after taking study medication
Secondary outcomes (15)
Episodes With Complete Relief of Vertigo as Vestibular Symptom
The number of episodes in which complete relief of vertigo symptoms (rating 0) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms (vertigo and unsteadiness/dizziness) wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 1 hour after taking study medication
Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms
The outcome was the number of episodes in which complete relief of symptoms of unsteadiness/dizziness (rating 0) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms (vertigo and unsteadiness/dizziness) wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 1 hour after taking study medication
Episodes With Headache Reduced From Moderate/Severe to None/Mild
The outcome was the number of episodes in which a reduction of headache symptoms (rating 0) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 1 hour after taking study medication
Episodes With Photophobia/Phonophobia Reduced From Moderate/Severe to None/Mild
The outcome was the number of episodes in which a reduction of symptoms (rating 0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 1 hour after taking study medication
Episodes With Sensitivity to Motion Reduced From Moderate/Severe to None/Mild
The outcome was the number of episodes in which a reduction of sensitivity to motion symptoms (rating 0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 1 hour after taking study medication
Episodes With Nausea/Vomiting Reduced From Moderate/Severe to None/Mild
The outcome was the number of episodes in which a reduction of symptoms (rating 0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 1 hour after taking study medication
Satisfaction With Treatment
Treatment Satisfaction Questionnaire for Medication (TSQM) assessed four domains of participants' satisfaction with treatment, with scale ranges from 0 (extremely dissatisfied) to 100 (not at all dissatisfied) for each of the categories (Effectiveness, Side Effects, Convenience, and Overall Satisfaction).
Measured: 48 hour after taking study medication
Health-Related Quality of Life
Short Form Survey - 12 (SF-12) assessed physical and mental well-being after taking study medication for each episode, generating composite scores in each domain from 12 questions. The range is 0-100 with higher scores indicated better physical and mental health functioning.
Measured: 48 hour after taking study medication
Side Effects
Number of adverse events experienced by participants. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 categorizes all domains of physical and psychological side effects, grading them 1-mild, 2-moderate, 3-severe, 4-life threatening, 5-death.
Measured: 48 hour after taking study medication
Episodes With Sustained Reduction in Severity of Vertigo From Moderate/Severe to None/Mild Without Additional Medication
Episodes in which participants achieved reduction of symptoms (from rating 2-3 to 0-1). After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 24 hours after taking study medication
Episodes With Sustained Reduction in Severity of Dizziness/Unsteadiness From Moderate/Severe to None/Mild Without Additional Medication
Episodes in which participants achieved reduction of symptoms (from rating 2-3 to 0-1). After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 24 hours after taking study medication
Episodes With Headache Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 24 hours after taking study medication
Episodes With Photophobia/Phonophobia Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 24 hours after taking study medication
Episodes With Sensitivity to Motion Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 24 hours after taking study medication
Episodes With Nausea/Vomiting Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Measured: 24 hours after taking study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startDec 2014
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular MigraineStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert W. Baloh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert W. Baloh, University of California, Los Angeles
- Investigators
- Robert W Baloh, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447991
- Sponsor's protocol ID
- IRB12-001549
- Status last verified
- Oct 2019
- First submitted
- 18 Mar 2015
- Last updated
- 4 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Staab JP, Eggers SDZ, Jen JC, LeMahieu AM, Geske JR, Liu H, Hofschulte DR, Gonzalez GR, Neff BA, Shepard NT, McCaslin DL, Baloh RW. Rizatriptan vs Placebo for Attacks of Vestibular Migraine: A Randomized Clinical Trial. JAMA Neurol. 2025 Jul 1;82(7):676-686. doi: 10.1001/jamaneurol.2025.1006.
PubMed 40354049
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Trial on Rizatriptan for Vestibular Migraine
- ClinicalTrials.gov ID
- NCT02447991
- Acronym / sponsor ID
- IRB12-001549
- Conditions
- Vestibular Migraine, Migrainous Vertigo
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Robert W. BalohUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Posted 4 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Suffering from dizzy spells and migraine headaches?
Vestibular Migraine (VM), a newly recognized type of migraine that causes bouts of dizziness.
University of California, Los Angeles (UCLA) and The Mayo Clinic is seeking people with VM to participate in a research study. The purpose of this study is to look at the natural history of VM and learn more about common symptoms. Investigators also want to learn the effects, both positive and negative, of the commonly used migraine drug, rizatriptan, when it is used for spells of dizziness in people with VM.
Patients may be eligible to participate if:
- Patients are between the ages of 18 \& 65
- Patients have a history of vestibular migraine
- Patients are able to maintain a vestibular symptom diary
The study includes 3 visits with compensation. All participants must complete questionnaires on dizziness, headache symptoms, general health and well-being, mental health, and a questionnaire on patient's satisfaction with study medication.
Detailed description
The primary Specific Aim is to conduct the first successful controlled study of a treatment for Vestibular Migraine. The investigators hypothesize that rizatriptan will be superior to a look alike inactive capsule for:
1a. Reducing the severity and duration of vertigo attacks in patients with Vestibular Migraine,
1b. Reducing the severity of symptoms commonly associated with vertigo attacks in patients with Vestibular Migraine (e.g., nausea, vomiting, motion sensitivity, gait disturbance, headache, light and sound sensitivity), and
1c. Improving treatment satisfaction and health-related quality of life in patients with Vestibular Migraine, and that
1d. Rizatriptan will be well tolerated by patients with Vestibular Migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboDuring the Treatment Phase, three placebo capsules will be administered to each subject. One capsule will be taken during one acute episode, until three episodes are treated with the study drug. |
| Rizatriptan | Experimental | Drug: RizatriptanDuring the Treatment Phase, three Rizatriptan capsules will be administered to each subject. One capsule will be taken during one acute episode, until three episodes are treated with the study drug. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Are between the ages of 18 \& 65
- Have a history of vestibular migraine
- Are able to maintain a vestibular symptom diary
- History that fulfills all criteria for VM as defined in Table 1, except that attacks must last at least 2 hours.
- At least 5 episodes
Key exclusion criteria (8 listed)
- Ménière's disease by The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) criteria60.
- Migraine with brainstem aura (formerly basilar-type migraine) by the International Classification of Headache Disorders (ICHD-3) criteria.14
- Ischemic heart disease, coronary artery vasospasm, uncontrolled hypertension.
- History of stroke or transient ischemic attack.
- History of using rizatriptan specifically to treat vestibular attacks.
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 |
|---|---|---|
| RizatriptanAlso: MaxaltDuring the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study. | Drug | Rizatriptan |
| PlaceboAlso: Sugar PillDuring the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study. | Drug | Placebo |
Primary outcome
Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild
Time frame: 1 hour after taking study medication
Episodes in which a reduction in symptom severity from moderate/severe (rating 2/3) at time of taking study medication to none/mild rating (0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms (vertigo and unsteadiness/dizziness) wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
Episodes With Symptoms of Unsteadiness/Dizziness Reduced From Moderate/Severe to None/Mild
Time frame: 1 hour after taking study medication
Episodes of unsteadiness/dizziness in which a reduction in symptom severity from moderate/severe (rating 2/3) to none/mild rating (0/1) was achieved. After taking study medication participants reported symptoms using a patient self-report of the severity of vestibular symptoms (vertigo and unsteadiness/dizziness) wherein 0=no symptoms, 1=mild symptoms (no interference with activities), 2=moderate symptoms (had to alter some activities), and 3=severe symptoms (had to stop most or all activities).
15 secondary outcomes
Episodes With Complete Relief of Vertigo as Vestibular Symptom
Time frame: 1 hour after taking study medication
Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms
Time frame: 1 hour after taking study medication
Episodes With Headache Reduced From Moderate/Severe to None/Mild
Time frame: 1 hour after taking study medication
Episodes With Photophobia/Phonophobia Reduced From Moderate/Severe to None/Mild
Time frame: 1 hour after taking study medication
Episodes With Sensitivity to Motion Reduced From Moderate/Severe to None/Mild
Time frame: 1 hour after taking study medication
Episodes With Nausea/Vomiting Reduced From Moderate/Severe to None/Mild
Time frame: 1 hour after taking study medication
Satisfaction With Treatment
Time frame: 48 hour after taking study medication
Health-Related Quality of Life
Time frame: 48 hour after taking study medication
Side Effects
Time frame: 48 hour after taking study medication
Episodes With Sustained Reduction in Severity of Vertigo From Moderate/Severe to None/Mild Without Additional Medication
Time frame: 24 hours after taking study medication
Episodes With Sustained Reduction in Severity of Dizziness/Unsteadiness From Moderate/Severe to None/Mild Without Additional Medication
Time frame: 24 hours after taking study medication
Episodes With Headache Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
Time frame: 24 hours after taking study medication
Episodes With Photophobia/Phonophobia Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
Time frame: 24 hours after taking study medication
Episodes With Sensitivity to Motion Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
Time frame: 24 hours after taking study medication
Episodes With Nausea/Vomiting Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
Time frame: 24 hours after taking study medication
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40354049Staab JP, Eggers SDZ, Jen JC, LeMahieu AM, Geske JR, Liu H, Hofschulte DR, Gonzalez GR, Neff BA, Shepard NT, McCaslin DL, Baloh RW. Rizatriptan vs Placebo for Attacks of Vestibular Migraine: A Randomized Clinical Trial. JAMA Neurol. 2025 Jul 1;82(7):676-686. doi: 10.1001/jamaneurol.2025.1006.
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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.
Robert W Baloh, M.D. principal investigator
University of California, Los Angeles
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rizatriptan in people with Vestibular Migraine and Migrainous Vertigo, run by Robert W. Baloh at 3 sites in United States.
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 19 inclusion and 8 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild (time frame: 1 hour after taking study medication). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02447991, which also lists 1 linked publication.
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 4 Nov 2021; AzTrials last refreshed its copy on 5 Nov 2026.