Vestibular Migraine Clinical Trial
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.
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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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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