A Phase 1 interventional study of Verapamil and Sertraline in Vestibular Migraine and Chronic Subjective Dizziness, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-24.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Diagnostic
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.
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.
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Exclusion criteria:
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.
Drug: Verapamil
Sertraline oral tablets administered in a flexible dose format ranging from 25 mg to 150 mg daily depending on severity of headache and dizziness.
Drug: Sertraline
Also known as: Calan SR, Covera-HS, Isoptin SR, Verelan PM
Also known as: Zoloft
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0 to Week 12
Mean Number of Acute Attacks Per Two Week Period
Acute attacks will be assessed every 2 weeks for 12 weeks.
Time frame: 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).
Time frame: 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).
Time frame: Week 0 to Week 12
Mean score for Dizziness on the Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS)
Dizziness symptoms will be assessed at 2 week intervals for 12 weeks. The Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS) consists of 5 questions, with a total possible score ranging from 0 (no disability) to 72 (extremely disruptive).
Time frame: Week 0 to Week 12
Mean score for Headache on the Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS)
Headache symptoms will be assessed at 2 week intervals for 12 weeks. The Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS) consists of 5 questions, with a total possible score ranging from 0 (no disability) to 72 (extremely disruptive).
Time frame: Week 0 to Week 12
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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