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
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