Clinical Trial: Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Randomized Cross-over Trial of Nortryptyline and Topiramate in the Initial Treatment of Vestibular Migraine.

Brief Summary:

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.

Detailed Summary:

After identification and trial entry, we will complete intake questionnaire to determine what type of vestibular migraine category the patients qualify for, a standard of care office visit with history and physical (Standard of Care) to review symptoms and previous treatment, patients height and weight (standard of care) will be obtained. Patients will complete a standard of care audiology assessment, and the following questionnaires: MSQ (Migraine Symptom Questionnaire) Version 2.1, DHI (Dizziness Questionnaire) , C-SSRS (Columbia Suicide Severity Rating Scale) and the MoSQ (Motion Sensitivity Questionnaire). All drug naive patients will undergo a one month lead in of treatment involving dietary and behavioral control of migraine. Emphasis will be given to cessation of known migraine triggers such as caffeine, sodas, chocolates, alcohol (especially red wine) and aged cheeses. Patients who have complete control of their symptoms with diet and behavior modification alone will be followed for a total of 4 months to determine the durability of symptom relief. Patients who fail behavior modification during the 2 to 4 month time point can chose to enter the drug treatment portion of the study, as defined below.

At the one month point, patients will be brought into the clinic for a office visit with history, physical, and weight checked and will complete MSQ V2.1, DHI, C-SSRS and the MoSQ, then will be randomization to either nortriptyline or topiramate will occur. Randomization will occur by opening the lowest numbered of a stack of envelopes which will contain a randomly preselected card indicating which drug is to be used. 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 medicatio
Sponsor: St. Louis University

Current Primary Outcome: evaluate the comparative effectiveness of migraine diet, nortriptyline and topiramate [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Louis University

Dates:
Date Received: June 17, 2014
Date Started: June 2014
Date Completion: September 2018
Last Updated: November 30, 2016
Last Verified: November 2016