Migrainous Vertigo, Vestibular Migraine
Conditions
Brief 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. 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.
Interventions
DRUGRizatriptan
During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study.
DRUGPlacebo
During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study.
Sponsors
Robert W. Baloh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Must answer yes to be eligible 1. Are between the ages of 18 & 65 2. Have a history of vestibular migraine 3. 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. 4. At least 5 episodes 5. A current or past history of migraine without aura or migraine with aura 6. Vestibular symptoms of moderate or severe intensity lasting at least 2 hours 7. 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 8. Experience photophobia and phonophobia 9. Experience visual aura 10. Episodes must have a spontaneous onset and resolution without associated hearing loss or interictal neurotologic deficits. 11. Other causes of vestibular symptoms ruled out by appropriate clinical investigations. 12. Current medication list compatible with Concomitant Medications below. 13. Able to maintain a Vestibular Symptom Diary and complete all other study procedures.
Exclusion criteria
Must answer no to be eligible. 1. Ménière's disease by The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) criteria60. 2. Migraine with brainstem aura (formerly basilar-type migraine) by the International Classification of Headache Disorders (ICHD-3) criteria.14 3. Ischemic heart disease, coronary artery vasospasm, uncontrolled hypertension. 4. History of stroke or transient ischemic attack. 5. History of using rizatriptan specifically to treat vestibular attacks. 6. History of adverse response to triptans or intolerance to lactose. 7. Women who are pregnant or breastfeeding. 8. Unable or unwilling to comply with study requirements for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episodes With Headache Reduced From Moderate/Severe to None/Mild | 1 hour after taking study medication | 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). |
| Episodes With Photophobia/Phonophobia Reduced From Moderate/Severe to None/Mild | 1 hour after taking study medication | 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). |
| Episodes With Sensitivity to Motion Reduced From Moderate/Severe to None/Mild | 1 hour after taking study medication | 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). |
| Episodes With Nausea/Vomiting Reduced From Moderate/Severe to None/Mild | 1 hour after taking study medication | 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). |
| Satisfaction With Treatment | 48 hour after taking study medication | 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). |
| Health-Related Quality of Life | 48 hour after taking study medication | 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 Complete Relief of Vertigo as Vestibular Symptom | 1 hour after taking study medication | 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). |
| Episodes With Sustained Reduction in Severity of Vertigo From Moderate/Severe to None/Mild Without Additional Medication | 24 hours after taking study 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). |
| Episodes With Sustained Reduction in Severity of Dizziness/Unsteadiness From Moderate/Severe to None/Mild Without Additional Medication | 24 hours after taking study 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). |
| Episodes With Headache Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication | 24 hours after taking study 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). |
| Episodes With Photophobia/Phonophobia Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication | 24 hours after taking study 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). |
| Episodes With Sensitivity to Motion Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication | 24 hours after taking study 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). |
| Episodes With Nausea/Vomiting Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication | 24 hours after taking study 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). |
| Side Effects | 48 hour after taking study medication | 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. |
| Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms | 1 hour after taking study medication | 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| Rizatriptan 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. | 89 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | End of study - no treatment results | 3 | 6 |
| Overall Study | End of study - partial treatment results | 0 | 9 |
| Overall Study | Lost to Follow-up - no data | 3 | 6 |
| Overall Study | Lost to follow-up - with data | 0 | 3 |
| Overall Study | Withdrawn by subject - no data | 0 | 2 |
| Overall Study | Withdrawn by Subject - with data | 4 | 4 |
Baseline characteristics
| Characteristic | Placebo | Rizatriptan | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 89 Participants | 134 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 9 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 40 Participants | 80 Participants | 120 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 9 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 39 Participants | 69 Participants | 108 Participants |
| Region of Enrollment United States | 45 participants | 89 participants | 134 participants |
| Sex: Female, Male Female | 32 Participants | 69 Participants | 101 Participants |
| Sex: Female, Male Male | 13 Participants | 20 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 89 |
| other Total, other adverse events | 45 / 45 | 89 / 89 |
| serious Total, serious adverse events | 0 / 45 | 0 / 89 |
Outcome results
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).
Time frame: 1 hour after taking study medication
Population: Participants who experienced episodes with moderate/severe symptoms were included in the analyses
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Symptoms of Unsteadiness/Dizziness Reduced From Moderate/Severe to None/Mild | 11 Episodes |
| Rizatriptan | Episodes With Symptoms of Unsteadiness/Dizziness Reduced From Moderate/Severe to None/Mild | 29 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medicationp-value: <0.18Chi-squared, Corrected
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).
Time frame: 1 hour after taking study medication
Population: Participants who experienced episodes with moderate/severe symptoms were included in the analyses
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild | 50 Episodes |
| Rizatriptan | Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild | 73 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.p-value: <0.33Chi-squared, Corrected
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).
Time frame: 1 hour after taking study medication
Population: Participants who experienced episodes with moderate/severe symptoms were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms | 2 Episodes |
| Rizatriptan | Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms | 12 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness as measured by the proportion of treated episodes in which subjects experience freedom from vestibular symptoms (i.e., severity rating of Grade 0) at 1 hour after taking study medication.p-value: <0.19Chi-squared, Corrected
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).
Time frame: 1 hour after taking study medication
Population: Participants who experienced episodes with moderate/severe symptoms were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Complete Relief of Vertigo as Vestibular Symptom | 35 Episodes |
| Rizatriptan | Episodes With Complete Relief of Vertigo as Vestibular Symptom | 56 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo as measured by the proportion of treated episodes in which subjects experience freedom from vestibular symptoms (i.e., severity rating of Grade 0) at 1 hour after taking study medication.p-value: <0.62Chi-squared, Corrected
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).
Time frame: 1 hour after taking study medication
Population: Participants who experienced episodes with moderate/severe symptoms were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Headache Reduced From Moderate/Severe to None/Mild | 38 Episodes |
| Rizatriptan | Episodes With Headache Reduced From Moderate/Severe to None/Mild | 44 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of headaches as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.p-value: <0.14Chi-squared, Corrected
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).
Time frame: 24 hours after taking study medication
Population: Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Headache Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication | 46 Episodes |
| Rizatriptan | Episodes With Headache Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication | 94 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of headaches measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.p-value: <0.12Chi-squared, Corrected
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).
Time frame: 1 hour after taking study medication
Population: Participants who experienced episodes with moderate/severe symptoms were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Nausea/Vomiting Reduced From Moderate/Severe to None/Mild | 50 Episodes |
| Rizatriptan | Episodes With Nausea/Vomiting Reduced From Moderate/Severe to None/Mild | 67 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of nausea/vomiting as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication..p-value: <0.35Chi-squared, Corrected
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).
Time frame: 24 hours after taking study medication
Population: Participants who experienced episodes with moderate/severe symptoms were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Nausea/Vomiting Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication | 57 Episodes |
| Rizatriptan | Episodes With Nausea/Vomiting Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication | 101 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of nausea/vomiting measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.p-value: <0.67Chi-squared, Corrected
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).
Time frame: 1 hour after taking study medication
Population: Participants who experienced episodes with moderate/severe symptoms were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Photophobia/Phonophobia Reduced From Moderate/Severe to None/Mild | 33 Episodes |
| Rizatriptan | Episodes With Photophobia/Phonophobia Reduced From Moderate/Severe to None/Mild | 59 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of photophobia/phonophobia as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.p-value: <0.72Chi-squared, Corrected
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).
Time frame: 24 hours after taking study medication
Population: Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Photophobia/Phonophobia Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication | 45 Episodes |
| Rizatriptan | Episodes With Photophobia/Phonophobia Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication | 95 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of photophobia/phonophobia measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.p-value: <0.051Chi-squared, Corrected
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).
Time frame: 1 hour after taking study medication
Population: Participants who experienced episodes with moderate/severe symptoms were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Sensitivity to Motion Reduced From Moderate/Severe to None/Mild | 19 Episodes |
| Rizatriptan | Episodes With Sensitivity to Motion Reduced From Moderate/Severe to None/Mild | 39 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of sensitivity to motion as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.p-value: <0.48Chi-squared, Corrected
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).
Time frame: 24 hours after taking study medication
Population: Participants who experienced episodes with moderate/severe symptoms were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Sensitivity to Motion Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication | 42 Episodes |
| Rizatriptan | Episodes With Sensitivity to Motion Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication | 95 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of sensitivity to motion measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.p-value: <0.006Chi-squared, Corrected
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).
Time frame: 24 hours after taking study medication
Population: Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Sustained Reduction in Severity of Dizziness/Unsteadiness From Moderate/Severe to None/Mild Without Additional Medication | 41 Episodes |
| Rizatriptan | Episodes With Sustained Reduction in Severity of Dizziness/Unsteadiness From Moderate/Severe to None/Mild Without Additional Medication | 90 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness episodes measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.p-value: <0.041Chi-squared, Corrected
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).
Time frame: 24 hours after taking study medication
Population: Participants who experienced episodes with moderate/severe symptoms were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Episodes With Sustained Reduction in Severity of Vertigo From Moderate/Severe to None/Mild Without Additional Medication | 54 Episodes |
| Rizatriptan | Episodes With Sustained Reduction in Severity of Vertigo From Moderate/Severe to None/Mild Without Additional Medication | 97 Episodes |
Comparison: Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.p-value: <0.76Chi-squared, Corrected
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.
Time frame: 48 hour after taking study medication
Population: Episodes with moderate/severe symptoms were included in the analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Health-Related Quality of Life | Physical well-being after study medication | 37.5 score on a scale | Standard Deviation 10.5 |
| Placebo | Health-Related Quality of Life | Mental well-being after study medication | 44.2 score on a scale | Standard Deviation 13.9 |
| Rizatriptan | Health-Related Quality of Life | Physical well-being after study medication | 41.9 score on a scale | Standard Deviation 8.9 |
| Rizatriptan | Health-Related Quality of Life | Mental well-being after study medication | 45.4 score on a scale | Standard Deviation 11.4 |
Comparison: Hypothesis: Rizatriptan will be superior to placebo on physical well-beingp-value: <0.009Regression, Linear
Comparison: Hypothesis: Rizatriptan will be superior to placebo on mental well-beingp-value: <0.467Regression, Linear
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).
Time frame: 48 hour after taking study medication
Population: Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Satisfaction With Treatment | Effectiveness | 37.2 score on a scale | Standard Deviation 27 |
| Placebo | Satisfaction With Treatment | Convenience | 70.0 score on a scale | Standard Deviation 17.4 |
| Placebo | Satisfaction With Treatment | Side Effects | 78.8 score on a scale | Standard Deviation 26 |
| Placebo | Satisfaction With Treatment | Overall Satisfaction | 45.9 score on a scale | Standard Deviation 27.1 |
| Rizatriptan | Satisfaction With Treatment | Side Effects | 81.6 score on a scale | Standard Deviation 22.6 |
| Rizatriptan | Satisfaction With Treatment | Effectiveness | 49.7 score on a scale | Standard Deviation 28.6 |
| Rizatriptan | Satisfaction With Treatment | Overall Satisfaction | 58.2 score on a scale | Standard Deviation 26.7 |
| Rizatriptan | Satisfaction With Treatment | Convenience | 71.0 score on a scale | Standard Deviation 17.8 |
Comparison: Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with effectiveness of study medicationp-value: <0.022Regression, Linear
Comparison: 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 medicationp-value: <0.418Regression, Linear
Comparison: 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 medicationp-value: <0.674Regression, Linear
Comparison: 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 medicationp-value: <0.016Regression, Linear
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.
Time frame: 48 hour after taking study medication
Population: Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Side Effects | Discontinuation due to adverse effects | 0 Adverse Events |
| Placebo | Side Effects | Hearth rhythm problems | 2 Adverse Events |
| Placebo | Side Effects | Chest pain or decreased exercise tolerance | 1 Adverse Events |
| Placebo | Side Effects | Swelling or puffiness | 0 Adverse Events |
| Placebo | Side Effects | Fever or chills | 0 Adverse Events |
| Placebo | Side Effects | Worsening of dizziness or gait | 3 Adverse Events |
| Placebo | Side Effects | Fatigue | 7 Adverse Events |
| Placebo | Side Effects | Sleepiness/Drowsiness | 11 Adverse Events |
| Placebo | Side Effects | Upset Stomach, nausea, vomiting | 8 Adverse Events |
| Placebo | Side Effects | Constipation or diarrhea | 3 Adverse Events |
| Placebo | Side Effects | Worsening of headache | 9 Adverse Events |
| Placebo | Side Effects | Ataxia | 1 Adverse Events |
| Placebo | Side Effects | Speech problems | 1 Adverse Events |
| Placebo | Side Effects | Weakness of arms/legs/face or loss of sensation | 5 Adverse Events |
| Placebo | Side Effects | Agitation | 1 Adverse Events |
| Placebo | Side Effects | Anxiety | 5 Adverse Events |
| Placebo | Side Effects | Serious adverse effects | 0 Adverse Events |
| Rizatriptan | Side Effects | Weakness of arms/legs/face or loss of sensation | 7 Adverse Events |
| Rizatriptan | Side Effects | Worsening of dizziness or gait | 15 Adverse Events |
| Rizatriptan | Side Effects | Hearth rhythm problems | 5 Adverse Events |
| Rizatriptan | Side Effects | Constipation or diarrhea | 3 Adverse Events |
| Rizatriptan | Side Effects | Chest pain or decreased exercise tolerance | 0 Adverse Events |
| Rizatriptan | Side Effects | Worsening of headache | 13 Adverse Events |
| Rizatriptan | Side Effects | Swelling or puffiness | 3 Adverse Events |
| Rizatriptan | Side Effects | Agitation | 5 Adverse Events |
| Rizatriptan | Side Effects | Fever or chills | 4 Adverse Events |
| Rizatriptan | Side Effects | Ataxia | 4 Adverse Events |
| Rizatriptan | Side Effects | Discontinuation due to adverse effects | 0 Adverse Events |
| Rizatriptan | Side Effects | Serious adverse effects | 0 Adverse Events |
| Rizatriptan | Side Effects | Fatigue | 44 Adverse Events |
| Rizatriptan | Side Effects | Speech problems | 3 Adverse Events |
| Rizatriptan | Side Effects | Sleepiness/Drowsiness | 51 Adverse Events |
| Rizatriptan | Side Effects | Anxiety | 12 Adverse Events |
| Rizatriptan | Side Effects | Upset Stomach, nausea, vomiting | 19 Adverse Events |
Comparison: Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to fatigue.p-value: <0.013Logistic regression with GEE
Comparison: Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to sleepiness/drowsinessp-value: <0.021Logistic regression with GEE