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NCT02169830 · ClinicalTrials.gov registry record · NA
Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine
A NA study, sponsored by St. Louis University.
- Terminated
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT02169830 is a NA study that was terminated before completion, run by St. Louis University. The registered enrollment target is 35 participants.
The verdict
NCT02169830, a NA study, was terminated before completion, sponsored by St. Louis University.
- TERMINATED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study 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.
Interventions
- DRUG Topiramate
- DRUG nortriptyline
- BEHAVIORAL Diet Modification
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2014-08-22 |
| Est. Completion | 2019-10-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02169830
The ClinicalTrials.gov registry entry for NCT02169830 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Topiramate is the first listed.
NCT02169830 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02169830 about?
NCT02169830 is a clinical study titled "Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine". 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 j...
What is the current status of trial NCT02169830?
This trial is currently terminated. It is a NA study. The enrollment target is 35 participants. The study started on 2014-08-22. Estimated completion is 2019-10-30.
What interventions are being tested in trial NCT02169830?
The interventions under investigation include: Topiramate (DRUG), nortriptyline (DRUG), Diet Modification (BEHAVIORAL).
Who is sponsoring clinical trial NCT02169830?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
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