Vestibular MigrainePhase 1NCT01669304
Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness
A Phase 1 study testing Verapamil and Sertraline in people with Vestibular Migraine and Chronic Subjective Dizziness, run by Mayo Clinic at 1 site in United States.
Trial summary
Vestibular migraine (VM) and chronic subjective dizziness (CSD) commonly cause vertigo, unsteadiness and dizziness. Clinical investigators are studying these illnesses to understand them better. VM and CSD occur together in about 1/3 of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Migraine, Chronic Subjective Dizziness
- What is being tested?
- Verapamil and Sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neurotologic diagnoses of both vestibular migraine and chronic subjective dizziness
- All other co-existing medical or psychiatric conditions are stable, and no greater than moderate severity
- Able to complete study assessments in person and by phone
- Able to travel to Mayo Clinic, Rochester, Minnesota for first and last study visits
- Willing to avoid pregnancy during study (abstinence or acceptable birth control)
Who cannot join
- Presence of any other active neurotologic diagnoses
- Medical or psychiatric conditions that would preclude or confound study drugs
- Use of medications or supplements that would preclude or confound study drugs
- Past treatment of headache or dizziness with a full trial of a calcium channel blocker or selective serotonin reuptake inhibitor
- Allergy to verapamil or sertraline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacologic Dissection of Vestibular Migraine and Chronic Subjective Dizziness: A Double-Blind Parallel Group Trial Comparing Response to Verapamil Versus Sertraline
Vestibular migraine (VM) and chronic subjective dizziness (CSD) commonly cause vertigo, unsteadiness and dizziness. Clinical investigators are studying these illnesses to understand them better. VM and CSD occur together in about 1/3 of patients. That makes it hard to diagnose them accurately and decide what treatments to use. As a result, doctors and patients may be confused about these diagnoses. The goal of this study was use two different medications to tease apart the symptoms of VM and CSD.
Patients who have VM and CSD together were given either verapamil or sertraline for 12 weeks. These medications are used to treat VM and CSD, though they are not approved for this purpose. Verapamil is believed to have stronger effects on symptoms of VM. Sertraline is believed to have stronger effects on symptoms of CSD. By comparing the responses of patients to these two medications, the researchers hoped to learn more about the key features of VM and CSD.
Read the detailed description
Chronic dizziness and recurrent vertigo are frequent complaints in primary and specialty medical care settings. Two common causes of these symptoms are vestibular migraine (VM) and chronic subjective dizziness (CSD), which may be seen in up to 25% of patients examined in tertiary neurotology centers. However, VM and CSD are relatively new diagnoses that have not yet been validated. Furthermore, recent research found that they co-exist 30% of the time with overlap in several features. From a clinical standpoint, this makes it difficult to diagnose and treat them well. From a research standpoint, it confounds subject selection for mechanistic investigations.
The primary goal of this study was to dissect VM and CSD in order to identify the key features and clarify the diagnostic criteria of each condition. Subjects diagnosed with coexisting VM-CSD were treated with either verapamil or sertraline. It was hypothesized that a differential treatment response to these two pharmacologic probes would help to tease apart the unique clinical features of VM and CSD and identify risk factors that are shared or separate between the two conditions. It was hoped that the different mechanisms of action of the two study medications might also shed light on the physiologic underpinnings of VM and CSD.
This project was a 14-week, prospective, randomized, double-blind, parallel group, pharmacologic dissection (PD) trial. A 12-week treatment period followed 2 weeks of baseline observation. Patients charted daily headache and vestibular symptoms. VM and CSD symptoms and potential confounds such as anxiety and depression were measured at two week intervals. Data were analyzed for differential and shared treatment effects that align with or oppose current concepts of VM and CSD.
A PD trial uses response to one or more pharmaceutical probes (drugs) to study physiologic mechanisms of illness. A PD trial may provide data to separate overlapping manifestations of comorbid illnesses. This is useful for conditions that lack biomarkers. It also may provide data to identify characteristics of illnesses (symptoms, signs, cellular processes) that are associated with specific pharmacologic mechanisms.
- Conditions
- Vestibular Migraine, Chronic Subjective Dizziness
- Being tested
- Verapamil, Sertraline
- Keywords
- migraine variant, chronic dizziness, pharmacologic dissection
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerapamilDrug
Also called Calan SR, Covera-HS, Isoptin SR, Verelan PM
SertralineDrug
Also called Zoloft
| Study group | Role | What they receive |
|---|---|---|
| Verapamil | Experimental | Verapamil extended release oral tablets administered in a flexible dose format ranging from 120 mg to 360 mg daily, as determined by severity of headache and dizziness. Receives: Drug: Verapamil |
| Sertraline | Experimental | Sertraline oral tablets administered in a flexible dose format ranging from 25 mg to 150 mg daily depending on severity of headache and dizziness. Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-week Average Rating of Severity of Headache from the Daily Symptom Diaries
Daily ratings of headache will be evaluated at 2 week intervals for 12 weeks.
Measured: Week 0 to Week 12
2-week Average Rating of Severity of Dizziness/Unsteadiness from the Daily Symptom Diaries
Daily ratings of dizziness/unsteadiness will be evaluated at 2 week intervals for 12 weeks.
Measured: Week 0 to Week 12
2-week Average Rating of Sensitivity to Motion of Self from the Daily Symptom Diaries
Daily ratings of sensitivity to motion of self will be evaluated at 2 week intervals for 12 weeks.
Measured: Week 0 to Week 12
2-week Average Rating of Sensitivity to Motion in the Environment from the Daily Symptom Diaries
Daily ratings of sensitivity to motion in the environment will be evaluated at 2 week intervals for 12 weeks.
Measured: Week 0 to Week 12
2-week Average Rating of Difficulty of Performing Precision Visual Tasks from the Daily Symptom Diaries
Daily ratings of difficulty of performing precision visual tasks will be evaluated at 2 week intervals for 12 weeks.
Measured: Week 0 to Week 12
Secondary outcomes (3)
Mean Number of Acute Attacks Per Two Week Period
Acute attacks will be assessed every 2 weeks for 12 weeks.
Measured: Week 0 to Week 12
Mean Score of Dizziness Handicap Inventory (DHI)
Dizziness related handicap will be assessed every 4 weeks for 12 weeks. The Dizziness Handicap Inventory (DHI) consists of 25 questions, with a total possible score ranging from 0 (no dizziness) to 50 (severe dizziness).
Measured: Week 0 to Week 12
Mean Score of Migraine-Specific Quality of Life (MSQ)
Quality of life related to headache will be assessed at 4 week intervals for 12 weeks. The Migraine-Specific Quality of Life 2.1 (MSQ) consists of 14 items, with a total possible score ranging from 14 (affected none of the time) to 84 (affected all of the time).
Measured: Week 0 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vestibular MigraineStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey P. Staab, Mayo Clinic
- Investigators
- Jeffrey Staab, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669304
- Sponsor's protocol ID
- 12-002814
- Status last verified
- Aug 2015
- First submitted
- 14 Aug 2012
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Staab JP, Ruckenstein MJ. Expanding the differential diagnosis of chronic dizziness. Arch Otolaryngol Head Neck Surg. 2007 Feb;133(2):170-6. doi: 10.1001/archotol.133.2.170.
PubMed 17309987Ruckenstein MJ, Staab JP. Chronic subjective dizziness. Otolaryngol Clin North Am. 2009 Feb;42(1):71-7, ix. doi: 10.1016/j.otc.2008.09.011.
PubMed 19134491Eggers SD, Staab JP, Neff BA, Goulson AM, Carlson ML, Shepard NT. Investigation of the coherence of definite and probable vestibular migraine as distinct clinical entities. Otol Neurotol. 2011 Sep;32(7):1144-51. doi: 10.1097/MAO.0b013e31822a1c67.
PubMed 21799457
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacologic Dissection of Vestibular Migraine and Chronic Subjective Dizziness: A Double-Blind Parallel Group Trial Comparing Response to Verapamil Versus Sertraline
- ClinicalTrials.gov ID
- NCT01669304
- Acronym / sponsor ID
- 12-002814
- Conditions
- Vestibular Migraine, Chronic Subjective Dizziness
- Keywords
- migraine variant, chronic dizziness, pharmacologic dissection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vestibular migraine (VM) and chronic subjective dizziness (CSD) commonly cause vertigo, unsteadiness and dizziness. Clinical investigators are studying these illnesses to understand them better. VM and CSD occur together in about 1/3 of patients. That makes it hard to diagnose them accurately and decide what treatments to use. As a result, doctors and patients may be confused about these diagnoses. The goal of this study was use two different medications to tease apart the symptoms of VM and CSD.
Patients who have VM and CSD together were given either verapamil or sertraline for 12 weeks. These medications are used to treat VM and CSD, though they are not approved for this purpose. Verapamil is believed to have stronger effects on symptoms of VM. Sertraline is believed to have stronger effects on symptoms of CSD. By comparing the responses of patients to these two medications, the researchers hoped to learn more about the key features of VM and CSD.
Detailed description
Chronic dizziness and recurrent vertigo are frequent complaints in primary and specialty medical care settings. Two common causes of these symptoms are vestibular migraine (VM) and chronic subjective dizziness (CSD), which may be seen in up to 25% of patients examined in tertiary neurotology centers. However, VM and CSD are relatively new diagnoses that have not yet been validated. Furthermore, recent research found that they co-exist 30% of the time with overlap in several features. From a clinical standpoint, this makes it difficult to diagnose and treat them well. From a research standpoint, it confounds subject selection for mechanistic investigations.
The primary goal of this study was to dissect VM and CSD in order to identify the key features and clarify the diagnostic criteria of each condition. Subjects diagnosed with coexisting VM-CSD were treated with either verapamil or sertraline. It was hypothesized that a differential treatment response to these two pharmacologic probes would help to tease apart the unique clinical features of VM and CSD and identify risk factors that are shared or separate between the two conditions. It was hoped that the different mechanisms of action of the two study medications might also shed light on the physiologic underpinnings of VM and CSD.
This project was a 14-week, prospective, randomized, double-blind, parallel group, pharmacologic dissection (PD) trial. A 12-week treatment period followed 2 weeks of baseline observation. Patients charted daily headache and vestibular symptoms. VM and CSD symptoms and potential confounds such as anxiety and depression were measured at two week intervals. Data were analyzed for differential and shared treatment effects that align with or oppose current concepts of VM and CSD.
A PD trial uses response to one or more pharmaceutical probes (drugs) to study physiologic mechanisms of illness. A PD trial may provide data to separate overlapping manifestations of comorbid illnesses. This is useful for conditions that lack biomarkers. It also may provide data to identify characteristics of illnesses (symptoms, signs, cellular processes) that are associated with specific pharmacologic mechanisms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verapamil | Experimental | Drug: VerapamilVerapamil extended release oral tablets administered in a flexible dose format ranging from 120 mg to 360 mg daily, as determined by severity of headache and dizziness. |
| Sertraline | Experimental | Drug: SertralineSertraline oral tablets administered in a flexible dose format ranging from 25 mg to 150 mg daily depending on severity of headache and dizziness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Neurotologic diagnoses of both vestibular migraine and chronic subjective dizziness
- All other co-existing medical or psychiatric conditions are stable, and no greater than moderate severity
- Able to complete study assessments in person and by phone
- Able to travel to Mayo Clinic, Rochester, Minnesota for first and last study visits
- Willing to avoid pregnancy during study (abstinence or acceptable birth control)
Key exclusion criteria (5 listed)
- Presence of any other active neurotologic diagnoses
- Medical or psychiatric conditions that would preclude or confound study drugs
- Use of medications or supplements that would preclude or confound study drugs
- Past treatment of headache or dizziness with a full trial of a calcium channel blocker or selective serotonin reuptake inhibitor
- Allergy to verapamil or sertraline
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 |
|---|---|---|
| VerapamilAlso: Calan SR, Covera-HS, Isoptin SR, Verelan PM | Drug | Verapamil |
| SertralineAlso: Zoloft | Drug | Sertraline |
Primary outcome
2-week Average Rating of Severity of Headache from the Daily Symptom Diaries
Time frame: Week 0 to Week 12
Daily ratings of headache will be evaluated at 2 week intervals for 12 weeks.
2-week Average Rating of Severity of Dizziness/Unsteadiness from the Daily Symptom Diaries
Time frame: Week 0 to Week 12
Daily ratings of dizziness/unsteadiness will be evaluated at 2 week intervals for 12 weeks.
2-week Average Rating of Sensitivity to Motion of Self from the Daily Symptom Diaries
Time frame: Week 0 to Week 12
Daily ratings of sensitivity to motion of self will be evaluated at 2 week intervals for 12 weeks.
2-week Average Rating of Sensitivity to Motion in the Environment from the Daily Symptom Diaries
Time frame: Week 0 to Week 12
Daily ratings of sensitivity to motion in the environment will be evaluated at 2 week intervals for 12 weeks.
2-week Average Rating of Difficulty of Performing Precision Visual Tasks from the Daily Symptom Diaries
Time frame: Week 0 to Week 12
Daily ratings of difficulty of performing precision visual tasks will be evaluated at 2 week intervals for 12 weeks.
3 secondary outcomes
Mean Number of Acute Attacks Per Two Week Period
Time frame: Week 0 to Week 12
Mean Score of Dizziness Handicap Inventory (DHI)
Time frame: Week 0 to Week 12
Mean Score of Migraine-Specific Quality of Life (MSQ)
Time frame: Week 0 to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
- Background: PubMed 17309987Staab JP, Ruckenstein MJ. Expanding the differential diagnosis of chronic dizziness. Arch Otolaryngol Head Neck Surg. 2007 Feb;133(2):170-6. doi: 10.1001/archotol.133.2.170.
- Background: PubMed 19134491Ruckenstein MJ, Staab JP. Chronic subjective dizziness. Otolaryngol Clin North Am. 2009 Feb;42(1):71-7, ix. doi: 10.1016/j.otc.2008.09.011.
- Background: PubMed 21799457Eggers SD, Staab JP, Neff BA, Goulson AM, Carlson ML, Shepard NT. Investigation of the coherence of definite and probable vestibular migraine as distinct clinical entities. Otol Neurotol. 2011 Sep;32(7):1144-51. doi: 10.1097/MAO.0b013e31822a1c67.
- additional research information from Mayo ClinicLink provided by the sponsor.
Related trials for Vestibular Migraine
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine
RecruitingPhase 4
Acute Treatment of Vestibular Migraine by Rimegepant
Vestibular Migraine
Not yet recruiting
Efficacy of Cognitive Behavioral Therapy at Vestibular Migraine
Cognitive Behavioral Therapy to Medical Treatment on Functional Ability of Patients With Vestibular Migraine
Not yet recruitingPhase 4
Effect of Atogepant on the Vestibulo-Ocular Reflex in Healthy Adults and Adults With Migraine
Migraine Disorders, Brain, Healthy Adult Participants
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.
Jeffrey Staab, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Verapamil and Sertraline in people with Vestibular Migraine and Chronic Subjective Dizziness, run by Mayo Clinic 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 5 inclusion and 5 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 24 Aug 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
2-week Average Rating of Severity of Headache from the Daily Symptom Diaries (time frame: Week 0 to Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01669304, which also lists 3 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 24 Aug 2015.