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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rizatriptan | Drug | During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 1 hour after taking study medication |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria: Must answer yes to be eligible
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
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:
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.
Exclusion Criteria: Must answer no to be eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Robert W Baloh, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40354049 | Derived | 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. |
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Of the 222 enrolled, 134 completed the observation period and moved on to the treatment phase, having had 2 qualifying episodes in the observation phase. Participants who did not have 2 qualifying episodes in the 12 month observation phase were withdrawn from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 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. Placebo: During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study. |
| FG001 | Rizatriptan | 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. Rizatriptan: During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | During the Treatment Phase, three placebo capsules were administered to each subject, one capsule to be taken during one acute episode, until three episodes are treated with the study drug. |
| BG001 | Rizatriptan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Participants who experienced episodes with moderate/severe symptoms were included in the analyses | Posted | Number | Episodes | 1 hour after taking study medication | Episodes of vertigo | Episodes of vertigo |
|
Up to 5 years
48 hours after each episode, until 3 episodes occur, up to 5 years of study duration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 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. Placebo: During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Staab, MD | Mayo Clnic | 507-293-9438 | staab.jeffrey@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2018 | Aug 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C093622 | rizatriptan |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Placebo | Drug | During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study. |
|
|
| 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | 24 hours after taking study medication |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| ICAHN School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Lost to Follow-up - no data |
|
| Lost to follow-up - with data |
|
| End of study - no treatment results |
|
| End of study - partial treatment results |
|
During the Treatment Phase, three Rizatriptan capsules were administered to each subject, one capsule to be taken during one acute episode, until three episodes are treated with the study drug.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Rizatriptan | Participants were instructed to treat three separate episodes of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally. |
|
|
|
| Primary | 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). | Participants who experienced episodes with moderate/severe symptoms were included in the analyses | Posted | Number | Episodes | 1 hour after taking study medication | Episodes of Unsteadiness/Dizziness | Episodes of Unsteadiness/Dizziness |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe symptoms were included in the analyses. | Posted | Number | Episodes | 1 hour after taking study medication | Episodes of vertigo | Episodes of vertigo |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe symptoms were included in the analyses. | Posted | Number | Episodes | 1 hour after taking study medication | Episodes of Unsteadiness/Dizziness | Episodes of Unsteadiness/Dizziness |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe symptoms were included in the analyses. | Posted | Number | Episodes | 1 hour after taking study medication | Episodes of headache | Episodes of headache |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe symptoms were included in the analyses. | Posted | Number | Episodes | 1 hour after taking study medication | Episodes of Photophobia/Phonophobia | Episodes of Photophobia/Phonophobia |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe symptoms were included in the analyses. | Posted | Number | Episodes | 1 hour after taking study medication | Episodes of Sensitivity to Motion | Episodes of Sensitivity to Motion |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe symptoms were included in the analyses. | Posted | Number | Episodes | 1 hour after taking study medication | Episodes of Nausea/Vomiting | Episodes of Nausea/Vomiting |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses. | Posted | Mean | Standard Deviation | score on a scale | 48 hour after taking study medication |
|
|
|
|
| Secondary | 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. | Episodes with moderate/severe symptoms were included in the analyses. | Posted | Mean | Standard Deviation | score on a scale | 48 hour after taking study medication | episodes of vestibular symptoms | episodes of vestibular symptoms |
|
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|
|
| Secondary | 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. | Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses. | Posted | Number | Adverse Events | 48 hour after taking study medication |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe symptoms were included in the analyses. | Posted | Number | Episodes | 24 hours after taking study medication | Episodes of vertigo | Episodes of vertigo |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses. | Posted | Number | Episodes | 24 hours after taking study medication | Episodes of Unsteadiness/Dizziness | Episodes of Unsteadiness/Dizziness |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses. | Posted | Number | Episodes | 24 hours after taking study medication | Episodes of headache | Episodes of headache |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses. | Posted | Number | Episodes | 24 hours after taking study medication | Episodes of photophobia/phonophobia | Episodes of photophobia/phonophobia |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe symptoms were included in the analyses. | Posted | Number | Episodes | 24 hours after taking study medication | Episodes of sensitivity to motion | Episodes of sensitivity to motion |
|
|
|
|
| Secondary | 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). | Participants who experienced episodes with moderate/severe symptoms were included in the analyses. | Posted | Number | Episodes | 24 hours after taking study medication | Episodes of nausea/vomiting | Episodes of nausea/vomiting |
|
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 45 |
| 45 |
| EG001 | Rizatriptan | 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. Rizatriptan: During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study. | 0 | 89 | 0 | 89 | 89 | 89 |
| Sleepiness/drowsiness | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Upset stomach, nausea, vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation or diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hearth rhythm problems | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest pain or decreased exercise tolerance | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Swelling or puffiness | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever or chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Worsening of dizziness or gait | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Worsening of headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ataxia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Speech problems | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weakness of arm/legs/face or loss of sensation | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Agitations | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| Convenience |
|
| Overall Satisfaction |
|
Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with side effects of study medication |
| Regression, Linear |
This analysis applies to proportion of treated episodes. |
| <0.418 |
Significance of threshold p<0.05 |
| Superiority |
| Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with convenience of study medication | Regression, Linear | This analysis applies to proportion of treated episodes. | <0.674 | Significance of threshold p<0.05 | Superiority |
| Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with overall satisfaction of study medication | Regression, Linear | This analysis applies to proportion of treated episodes. | <0.016 | Significance of threshold of p<0.05 | Superiority |
Hypothesis: Rizatriptan will be superior to placebo on mental well-being |
| Regression, Linear |
This analysis applies to proportion of treated episodes. |
| <0.467 |
Significance threshold p<0.05 |
| Superiority |
| Upset Stomach, nausea, vomiting |
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| Constipation or diarrhea |
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| Hearth rhythm problems |
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| Chest pain or decreased exercise tolerance |
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| Swelling or puffiness |
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| Fever or chills |
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| Worsening of dizziness or gait |
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| Worsening of headache |
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| Ataxia |
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| Speech problems |
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| Weakness of arms/legs/face or loss of sensation |
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| Agitation |
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| Anxiety |
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| Serious adverse effects |
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| Discontinuation due to adverse effects |
|
Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to sleepiness/drowsiness |
| Logistic regression with GEE |
GEE=generalized estimating equations - this accounts for repeated measures within patients. This analysis applies to proportion of treated episodes. |
| <0.021 |
Significance threshold p<0.05 |
| Superiority |