MigraineNCT00360282
Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?
A study testing Rizatriptan in people with Migraine, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers motion sickness in migraine sufferers. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Migraine
- What is being tested?
- Rizatriptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of motion sickness
- Currently suffering from migraines with at least 2 episodes during the previous 12 months
- Previous use and tolerance to triptans
Who cannot join
- Current tobacco user
- History of or current hypertension, cardiac disease, arrhythmia, hypercholesterolemia, hemiplegic/basilar migraine, stroke, diabetes, vascular disease or kidney disease
- Family history of early myocardial infarction (first-degree relative < 45 years old at time of event)
- Constant dizziness or constant vestibular symptoms
- History of ear, nose and throat (ENT) disease, e.g. Meniere's disease
- Current treatment with propranolol or medications that would preclude use of a triptan(e.g. ergotamine)
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- Major vestibular abnormality found on screening
- Testing positive on over-the-counter pregnancy test
- Taken an Monamine Oxidase (MAO) inhibitor within two weeks of testing
- Allergy or intolerance to gelatin
- Corrected visual acuity of > 20/40 O.U.
- Women who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs
The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers motion sickness in migraine sufferers.
Read the detailed description
Migraine sufferers undergo vestibular tests and were excluded if there were clinically significant abnormalities. Following screening, there were 2 experimental visits in which migraine sufferers were pre-treated with either Rizatriptan or placebo. After taking the drug, subjects were idle for 2 hours. Baseline motion sickness and subjective units of distress levels were assessed prior to undergoing sinusoidal-earth-vertical earth axis rotation in darkness at 0.05 Hz. Scores were taken immediately after stopping. Subjects were given a 2 minutes rest and then underwent a motion sickness provoking rotation. Subjective scores were assessed immediately following. Another two minute rest was given and if the subject was able, underwent a second motion sickness provoking stimulus followed by an assessment.
- Conditions
- Migraine
- Being tested
- Rizatriptan, Placebo
- Keywords
- Migraine, Triptans, Motion Sickness
- Medical subject headings
- Migraine Disorders, Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RizatriptanDrug
Also called Maxalt
10 mg Rizatriptan in an unlabeled pill given once on one of two visits
PlaceboOther
Also called Sugar Pill
In an unlabeled pill given once on one of two visits.
| Study group | Role | What they receive |
|---|---|---|
| With Vertigo; Placebo - Rizatriptan | Other | This group received placebo on visit 1 and Rizatriptan on visit 2. Receives: Drug: Rizatriptan; Other: Placebo |
| With Vertigo; Rizatriptan - Placebo | Other | These subjects received Rizatriptan on visit 1 and placebo on visit 2. Receives: Drug: Rizatriptan; Other: Placebo |
| Without Vertigo; Placebo - Rizatriptan | Other | This group received placebo on visit 1 and Rizatriptan on visit 2. Receives: Drug: Rizatriptan; Other: Placebo |
| Without Vertigo; Rizatriptan-Placebo | Other | This group received Rizatriptan on visit 1 and placebo on visit 2. Receives: Drug: Rizatriptan; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Motion Sickness to Post Vestibular Stimulus
Scores are based on a scale developed by Graybiel which rates seven subjective and objective signs of motion sickness. The total scores ranged from from 0 to 25. Zero indicating no motion sickness. Greater than 16 indicates severe motion sickness. Trials were stopped if scores were 16 or greater. Scores were taken before and after each rotation.
Measured: Pre and Post Stimulus (about 6 minutes apart)
Secondary outcomes (1)
Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus
Subjective report of distress ranging from 0 to 10 based on the method of Wolpe. Zero indicates no distress and 10 indicates severe distress. Measures used in this analysis match the times used in the analysis for Outcome 1.
Measured: Pre and Post Stimulus (6 minutes apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Joseph Furman, University of Pittsburgh
- Investigators
- Joseph M Furman, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360282
- Sponsor's protocol ID
- 0602009
- Other IDs
- 31449
- Status last verified
- Dec 2014
- First submitted
- 2 Aug 2006
- Last updated
- 8 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Furman JM, Marcus DA, Balaban CD. Rizatriptan reduces vestibular-induced motion sickness in migraineurs. J Headache Pain. 2011 Feb;12(1):81-8. doi: 10.1007/s10194-010-0250-z. Epub 2010 Sep 23.
PubMed 20862509Webster KE, Dor A, Galbraith K, Haj Kassem L, Harrington-Benton NA, Judd O, Kaski D, Maarsingh OR, MacKeith S, Ray J, Van Vugt VA, Burton MJ. Pharmacological interventions for acute attacks of vestibular migraine. Cochrane Database Syst Rev. 2023 Apr 12;4(4):CD015322. doi: 10.1002/14651858.CD015322.pub2.
PubMed 37042545
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs
- ClinicalTrials.gov ID
- NCT00360282
- Acronym / sponsor ID
- 0602009
- Conditions
- Migraine
- Keywords
- Migraine, Triptans, Motion Sickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Aug 2006 (estimated)
- Results
- Posted 8 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers motion sickness in migraine sufferers.
Detailed description
Migraine sufferers undergo vestibular tests and were excluded if there were clinically significant abnormalities. Following screening, there were 2 experimental visits in which migraine sufferers were pre-treated with either Rizatriptan or placebo. After taking the drug, subjects were idle for 2 hours. Baseline motion sickness and subjective units of distress levels were assessed prior to undergoing sinusoidal-earth-vertical earth axis rotation in darkness at 0.05 Hz. Scores were taken immediately after stopping. Subjects were given a 2 minutes rest and then underwent a motion sickness provoking rotation. Subjective scores were assessed immediately following. Another two minute rest was given and if the subject was able, underwent a second motion sickness provoking stimulus followed by an assessment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| With Vertigo; Placebo - Rizatriptan | Other | Drug: Rizatriptan, Other: PlaceboThis group received placebo on visit 1 and Rizatriptan on visit 2. |
| With Vertigo; Rizatriptan - Placebo | Other | Drug: Rizatriptan, Other: PlaceboThese subjects received Rizatriptan on visit 1 and placebo on visit 2. |
| Without Vertigo; Placebo - Rizatriptan | Other | Drug: Rizatriptan, Other: PlaceboThis group received placebo on visit 1 and Rizatriptan on visit 2. |
| Without Vertigo; Rizatriptan-Placebo | Other | Drug: Rizatriptan, Other: PlaceboThis group received Rizatriptan on visit 1 and placebo on visit 2. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- History of motion sickness
- Currently suffering from migraines with at least 2 episodes during the previous 12 months
- Previous use and tolerance to triptans
Key exclusion criteria (12 listed)
- Current tobacco user
- History of or current hypertension, cardiac disease, arrhythmia, hypercholesterolemia, hemiplegic/basilar migraine, stroke, diabetes, vascular disease or kidney disease
- Family history of early myocardial infarction (first-degree relative < 45 years old at time of event)
- Constant dizziness or constant vestibular symptoms
- History of ear, nose and throat (ENT) disease, e.g. Meniere's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RizatriptanAlso: Maxalt10 mg Rizatriptan in an unlabeled pill given once on one of two visits | Drug | With Vertigo; Placebo - Rizatriptan, With Vertigo; Rizatriptan - Placebo, Without Vertigo; Placebo - Rizatriptan, Without Vertigo; Rizatriptan-Placebo |
| PlaceboAlso: Sugar PillIn an unlabeled pill given once on one of two visits. | Other | With Vertigo; Placebo - Rizatriptan, With Vertigo; Rizatriptan - Placebo, Without Vertigo; Placebo - Rizatriptan, Without Vertigo; Rizatriptan-Placebo |
Primary outcome
Change From Baseline in Motion Sickness to Post Vestibular Stimulus
Time frame: Pre and Post Stimulus (about 6 minutes apart)
Scores are based on a scale developed by Graybiel which rates seven subjective and objective signs of motion sickness. The total scores ranged from from 0 to 25. Zero indicating no motion sickness. Greater than 16 indicates severe motion sickness. Trials were stopped if scores were 16 or greater. Scores were taken before and after each rotation.
1 secondary outcome
Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus
Time frame: Pre and Post Stimulus (6 minutes apart)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20862509Furman JM, Marcus DA, Balaban CD. Rizatriptan reduces vestibular-induced motion sickness in migraineurs. J Headache Pain. 2011 Feb;12(1):81-8. doi: 10.1007/s10194-010-0250-z. Epub 2010 Sep 23.
- Derived from this study: PubMed 37042545Webster KE, Dor A, Galbraith K, Haj Kassem L, Harrington-Benton NA, Judd O, Kaski D, Maarsingh OR, MacKeith S, Ray J, Van Vugt VA, Burton MJ. Pharmacological interventions for acute attacks of vestibular migraine. Cochrane Database Syst Rev. 2023 Apr 12;4(4):CD015322. doi: 10.1002/14651858.CD015322.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph M Furman, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rizatriptan in people with Migraine, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Motion Sickness to Post Vestibular Stimulus (time frame: Pre and Post Stimulus (about 6 minutes apart)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00360282, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.