Rizatriptan for Episodic Dizziness in Vestibular Migraine

• Sponsor: Robert W. Baloh (Other)
• Overall Status: Completed
• CT.gov ID: NCT02447991
• Collaborator: (none)
• Enrollment: 223
• Locations: 3
• Arms: 2
• Actual Duration (Months): 68
• Patients Per Site: 74.3
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vestibular Migraine; Migrainous Vertigo	Drug: Rizatriptan; Drug: Placebo	Phase 2/Phase 3

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

• Study Type: Interventional
• Actual Enrollment: 223 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase II/III Trial on Rizatriptan for Vestibular Migraine
• Actual Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Jul 31, 2020
• Actual Study Completion Date: Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Drug: Placebo; During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study.; Other Names: Sugar Pill
Experimental: 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.	Drug: Rizatriptan; During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study.; Other Names: Maxalt

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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 Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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).

5. 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).

6. 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).

7. 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).

8. 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.

9. 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.

10. 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).

11. 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).

12. 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).

13. 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).

14. 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).

15. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

1. At least 5 episodes

2. A current or past history of migraine without aura or migraine with aura

3. Vestibular symptoms of moderate or severe intensity lasting at least 2 hours

4. 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

1. Experience photophobia and phonophobia

2. Experience visual aura

3. Episodes must have a spontaneous onset and resolution without associated hearing loss or interictal neurotologic deficits.

4. Other causes of vestibular symptoms ruled out by appropriate clinical investigations.

5. Current medication list compatible with Concomitant Medications below.

6. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095
2	Mayo Clinic	Rochester	Minnesota	United States	55905
3	ICAHN School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Robert W. Baloh

Investigators

• Principal Investigator: Robert W Baloh, M.D., University of California, Los Angeles

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 22, 2018

More Information

Publications

None provided.

• Responsible Party: Robert W. Baloh, Robert W. Baloh, M.D., UCLA Principal Investigator/Study Chair, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT02447991
• Other Study ID Numbers: IRB12-001549
• First Posted: May 19, 2015
• Last Update Posted: Nov 4, 2021
• Last Verified: Oct 1, 2019

• Additional relevant MeSH terms: Vertigo; Migraine Disorders; Rizatriptan

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	45	89
COMPLETED	35	59
NOT COMPLETED	10	30

Baseline Characteristics

Arm/Group Title	Placebo	Rizatriptan	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	45	89	134
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	45 100%	89 100%	134 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	32 71.1%	69 77.5%	101 75.4%
Male	13 28.9%	20 22.5%	33 24.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 4.4%	9 10.1%	11 8.2%
Not Hispanic or Latino	3 6.7%	0 0%	3 2.2%
Unknown or Not Reported	40 88.9%	80 89.9%	120 89.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	5 11.1%	9 10.1%	14 10.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	7 7.9%	7 5.2%
White	39 86.7%	69 77.5%	108 80.6%
More than one race	1 2.2%	1 1.1%	2 1.5%
Unknown or Not Reported	0 0%	3 3.4%	3 2.2%
Region of Enrollment (participants) [Number]
United States	45 100%	89 100%	134 100%

Outcome Measures

1. Primary Outcome

Title	Episodes With Vertigo Symptom Reduced From Moderate/Severe to None/Mild
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe symptoms were included in the analyses

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate episodes of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate episodes of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of vertigo	88	151
Number [Episodes]	50	73

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.33
	Comments	Significance level p < 0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes.

2. Primary Outcome

Title	Episodes With Symptoms of Unsteadiness/Dizziness Reduced From Moderate/Severe to None/Mild
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe symptoms were included in the analyses

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate episodes of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate episodes of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of Unsteadiness/Dizziness	89	151
Number [Episodes]	11	29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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 medication
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.18
	Comments	Signficant at p < 0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes

3. Secondary Outcome

Title	Episodes With Complete Relief of Vertigo as Vestibular Symptom
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of vertigo	88	151
Number [Episodes]	35	56

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.62
	Comments	Significance threshold p<0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes.

4. Secondary Outcome

Title	Episodes With Complete Relief of Unsteadiness/Dizziness Vestibular Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of Unsteadiness/Dizziness	89	151
Number [Episodes]	2	12

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.19
	Comments	Significance threshold p < 0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportions of treated episodes

5. Secondary Outcome

Title	Episodes With Headache Reduced From Moderate/Severe to None/Mild
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of headache	89	149
Number [Episodes]	38	44

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.14
	Comments	Significance threshold p<0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes.

6. Secondary Outcome

Title	Episodes With Photophobia/Phonophobia Reduced From Moderate/Severe to None/Mild
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of Photophobia/Phonophobia	89	151
Number [Episodes]	33	59

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.72
	Comments	Significance threshold p < 0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes

7. Secondary Outcome

Title	Episodes With Sensitivity to Motion Reduced From Moderate/Severe to None/Mild
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of Sensitivity to Motion	89	151
Number [Episodes]	19	39

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.48
	Comments	Significance threshold p < 0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes

8. Secondary Outcome

Title	Episodes With Nausea/Vomiting Reduced From Moderate/Severe to None/Mild
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of Nausea/Vomiting	89	150
Number [Episodes]	50	67

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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..
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.35
	Comments	Significance threshold p < 0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes

9. Secondary Outcome

Title	Satisfaction With Treatment
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants meeting International Headache Society and International Classification of Vestibular Disorders criteria for vestibular migraine and experiencing at least two attacks documented during the 12-month prospective observation phase of this study were randomized in a 2:1 ratio to rizatriptan versus placebo. Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants meeting International Headache Society and International Classification of Vestibular Disorders criteria for vestibular migraine and experiencing at least two attacks documented during the 12-month prospective observation phase of this study were randomized in a 2:1 ratio to rizatriptan versus placebo. Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Effectiveness	37.2 (27.0)	49.7 (28.6)
Side Effects	78.8 (26.0)	81.6 (22.6)
Convenience	70.0 (17.4)	71.0 (17.8)
Overall Satisfaction	45.9 (27.1)	58.2 (26.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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 medication
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.022
	Comments	Significance of threshold p<0.05
	Method	Regression, Linear
	Comments	This analysis applies to proportion of treated episodes.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.418
	Comments	Significance of threshold p<0.05
	Method	Regression, Linear
	Comments	This analysis applies to proportion of treated episodes.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.674
	Comments	Significance of threshold p<0.05
	Method	Regression, Linear
	Comments	This analysis applies to proportion of treated episodes.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.016
	Comments	Significance of threshold of p<0.05
	Method	Regression, Linear
	Comments	This analysis applies to proportion of treated episodes.

10. Secondary Outcome

Title	Health-Related Quality of Life
Description	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

Outcome Measure Data

Analysis Population Description

Episodes with moderate/severe symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure episodes of vestibular symptoms	89	151
Physical well-being after study medication	37.5 (10.5)	41.9 (8.9)
Mental well-being after study medication	44.2 (13.9)	45.4 (11.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	Hypothesis: Rizatriptan will be superior to placebo on physical well-being
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.009
	Comments	Significance threshold p<0.05
	Method	Regression, Linear
	Comments	This analysis applies to proportion of treated episodes.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	Hypothesis: Rizatriptan will be superior to placebo on mental well-being
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.467
	Comments	Significance threshold p<0.05
	Method	Regression, Linear
	Comments	This analysis applies to proportion of treated episodes.

11. Secondary Outcome

Title	Side Effects
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Fatigue	7	44
Sleepiness/Drowsiness	11	51
Upset Stomach, nausea, vomiting	8	19
Constipation or diarrhea	3	3
Hearth rhythm problems	2	5
Chest pain or decreased exercise tolerance	1	0
Swelling or puffiness	0	3
Fever or chills	0	4
Worsening of dizziness or gait	3	15
Worsening of headache	9	13
Ataxia	1	4
Speech problems	1	3
Weakness of arms/legs/face or loss of sensation	5	7
Agitation	1	5
Anxiety	5	12
Serious adverse effects	0	0
Discontinuation due to adverse effects	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to fatigue.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.013
	Comments	Significance threshold p<0.05
	Method	Logistic regression with GEE
	Comments	GEE=generalized estimating equations - this accounts for repeated measures within patients.This analysis applies to proportion of treated episodes.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to sleepiness/drowsiness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.021
	Comments	Significance threshold p<0.05
	Method	Logistic regression with GEE
	Comments	GEE=generalized estimating equations - this accounts for repeated measures within patients. This analysis applies to proportion of treated episodes.

12. Secondary Outcome

Title	Episodes With Sustained Reduction in Severity of Vertigo From Moderate/Severe to None/Mild Without Additional Medication
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of vertigo	61	109
Number [Episodes]	54	97

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.76
	Comments	Significance threshold p<0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes.

13. Secondary Outcome

Title	Episodes With Sustained Reduction in Severity of Dizziness/Unsteadiness From Moderate/Severe to None/Mild Without Additional Medication
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of Unsteadiness/Dizziness	62	109
Number [Episodes]	41	90

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.041
	Comments	Significance threshold p < 0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes.

14. Secondary Outcome

Title	Episodes With Headache Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of headache	62	109
Number [Episodes]	46	94

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.12
	Comments	Significance threshold p<0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes.

15. Secondary Outcome

Title	Episodes With Photophobia/Phonophobia Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe vestibular symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of photophobia/phonophobia	62	109
Number [Episodes]	45	95

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.051
	Comments	Significance threshold p<0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes.

16. Secondary Outcome

Title	Episodes With Sensitivity to Motion Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of sensitivity to motion	62	109
Number [Episodes]	42	95

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.006
	Comments	Significance threshold p<0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes.

17. Secondary Outcome

Title	Episodes With Nausea/Vomiting Symptoms Reduced From Moderate/Severe (3/4) to None/Mild (0/1) Without Additional Medication
Description	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

Outcome Measure Data

Analysis Population Description

Participants who experienced episodes with moderate/severe symptoms were included in the analyses.

Arm/Group Title	Placebo	Rizatriptan
Arm/Group Description	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (placebo capsule) orally.	Participants were instructed to treat three separate attacks of moderate to server vestibular symptoms with study drug, (rizatriptan 10 mg) orally.
Measure Participants	39	75
Measure Episodes of nausea/vomiting	62	108
Number [Episodes]	57	101

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rizatriptan
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.67
	Comments	Significance threshold p<0.05
	Method	Chi-squared, Corrected
	Comments	This analysis applies to proportion of treated episodes.

Adverse Events

Time Frame	Up to 5 years
Adverse Event Reporting Description	48 hours after each episode, until 3 episodes occur, up to 5 years of study duration
Arm/Group Title	Placebo		Rizatriptan
Arm/Group Description	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.		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.
All Cause Mortality
	Placebo		Rizatriptan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/89 (0%)
Serious Adverse Events
	Placebo		Rizatriptan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/89 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Rizatriptan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/45 (100%)		89/89 (100%)
Cardiac disorders
Hearth rhythm problems	2/45 (4.4%)	2	5/89 (5.6%)	5
Chest pain or decreased exercise tolerance	1/45 (2.2%)	1	0/89 (0%)	0
Gastrointestinal disorders
Upset stomach, nausea, vomiting	8/45 (17.8%)	8	19/89 (21.3%)	19
Constipation or diarrhea	3/45 (6.7%)	3	3/89 (3.4%)	3
General disorders
Fatigue	7/45 (15.6%)	7	44/89 (49.4%)	44
Sleepiness/drowsiness	11/45 (24.4%)	11	51/89 (57.3%)	51
Swelling or puffiness	0/45 (0%)	0	3/89 (3.4%)	3
Fever or chills	0/45 (0%)	0	4/89 (4.5%)	4
Musculoskeletal and connective tissue disorders
Ataxia	1/45 (2.2%)	1	4/89 (4.5%)	4
Weakness of arm/legs/face or loss of sensation	5/45 (11.1%)	5	7/89 (7.9%)	7
Nervous system disorders
Worsening of dizziness or gait	3/45 (6.7%)	3	15/89 (16.9%)	15
Worsening of headache	9/45 (20%)	9	13/89 (14.6%)	13
Speech problems	1/45 (2.2%)	1	3/89 (3.4%)	3
Psychiatric disorders
Agitations	1/45 (2.2%)	1	5/89 (5.6%)	5
Anxiety	5/45 (11.1%)	5	12/89 (13.5%)	12

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.