Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 07/31/2015 |
| Primero enviado: | 08/13/2012 |
| Inscripción estimada enviada: | 08/15/2012 |
| Publicado por primera vez: | 08/20/2012 |
| Última actualización enviada: | 08/19/2015 |
| Última actualización publicada: | 08/23/2015 |
| Fecha de inicio real del estudio: | 07/31/2012 |
| Fecha estimada de finalización primaria: | 09/30/2014 |
| Fecha estimada de finalización del estudio: | 09/30/2014 |
Condición o enfermedad
Intervención / tratamiento
Drug: Verapamil
Drug: Sertraline
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Verapamil 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 |
| Experimental: Sertraline 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 |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion criteria: 1. Neurotologic diagnoses of both vestibular migraine and chronic subjective dizziness 2. All other co-existing medical or psychiatric conditions are stable, and no greater than moderate severity 3. Able to complete study assessments in person and by phone 4. Able to travel to Mayo Clinic, Rochester, Minnesota for first and last study visits 5. Willing to avoid pregnancy during study (abstinence or acceptable birth control) Exclusion criteria: 1. Presence of any other active neurotologic diagnoses 2. Medical or psychiatric conditions that would preclude or confound study drugs 3. Use of medications or supplements that would preclude or confound study drugs 4. Past treatment of headache or dizziness with a full trial of a calcium channel blocker or selective serotonin reuptake inhibitor 5. Allergy to verapamil or sertraline |
Salir
Medidas de resultado primarias
1. 2-week Average Rating of Severity of Headache from the Daily Symptom Diaries [Week 0 to Week 12]
2. 2-week Average Rating of Severity of Dizziness/Unsteadiness from the Daily Symptom Diaries [Week 0 to Week 12]
3. 2-week Average Rating of Sensitivity to Motion of Self from the Daily Symptom Diaries [Week 0 to Week 12]
4. 2-week Average Rating of Sensitivity to Motion in the Environment from the Daily Symptom Diaries [Week 0 to Week 12]
5. 2-week Average Rating of Difficulty of Performing Precision Visual Tasks from the Daily Symptom Diaries [Week 0 to Week 12]
Medidas de resultado secundarias
1. Mean Number of Acute Attacks Per Two Week Period [Week 0 to Week 12]
2. Mean Score of Dizziness Handicap Inventory (DHI) [Week 0 to Week 12]
3. Mean Score of Migraine-Specific Quality of Life (MSQ) [Week 0 to Week 12]
Otras medidas de resultado
1. Mean score for Dizziness on the Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS) [Week 0 to Week 12]
2. Mean score for Headache on the Sheehan Disability Scale/Migraine Disability Assessment Scale (SDS-MIDAS) [Week 0 to Week 12]
