Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine
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|ClinicalTrials.gov Identifier: NCT02169830|
Recruitment Status : Terminated (Lack of enrollment)
First Posted : June 23, 2014
Last Update Posted : January 18, 2020
The investigators' study plans to randomize treatment naive patients with vestibular migraine to an 8 week trial of an escalating dose of either nortriptyline or topiramate followed by an 8 week crossover to the other drug if patient is willing, if patient wants to stay on first medication we will just continue to follow. During the first 8 weeks if there is an intolerance to the first drug they can be switched to the other drug at any point and then followed on that medication for the remainder of the study. Response to therapy will be quantified by the Migraine Specific Quality of Life (MSQ) and Dizziness Handicap Inventory (DHI) administered at multiple time points during the study. Three groups of patients that will be eligible for the study will include 1)Patients with Neuhauser dVM; 2)Patients with pVM; and 3) Patients with dizziness that falls outside the Neuhauser criteria (non-Neuhauser vestibular migraine or nNVM).
The investigators' hypothesis is that even patients with dizziness outside of the Neuhauser dVM and pVM spectrum will respond to treatment for vestibular migraine, and thus likely have migraine as a cause of their dizziness. Previous research by our group has suggested that such patients do in fact respond to migraine therapy1. A second goal of the study is to evaluate the comparative efficacy of nortriptyline and topiramate in the treatment of these three subgroups of patients with vestibular migraine.
|Condition or disease||Intervention/treatment||Phase|
|Migraine Disorders||Drug: nortriptyline Drug: Topiramate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Cross-over Trial of Nortryptyline and Topiramate in the Initial Treatment of Vestibular Migraine.|
|Actual Study Start Date :||May 13, 2014|
|Actual Primary Completion Date :||October 30, 2019|
|Actual Study Completion Date :||October 30, 2019|
Active Comparator: nortriptyline
Diet modification - nortriptyline and then if necessary topiramate
The nortriptyline will be given in an escalating fashion, starting at 25 mg PO qhs for 2 weeks, followed by 50 mg PO qhs for 2 weeks, and finally 75 mg PO qhs. Patients will be encouraged to use the lowest effective dose and to self-titrate their medication.
Other Name: Nortriptyline HCI
Active Comparator: topiramate
Diet Modification topiramate and then nortriptyline if necessary
Topiramate dosing will be 25 mg PO qhs for 1 week, followed by 25 mg BID for 1 week, followed by 25 mg in the morning and 50 mg qhs for 1 week, and finally 50 mg BID
Other Name: Topamax
- evaluate the comparative effectiveness of migraine diet, nortriptyline and topiramate [ Time Frame: one year ]Changes in Migraine Specific Quality of LIfe (MSQ) and Dizziness Handicap Inventory (DHI) between groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169830
|United States, Missouri|
|Saint Louis University|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Anthony A Mikulec, MD||St. Louis University|