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

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Anthony A. Mikulec, MD, St. Louis University
Sponsor:
Information provided by (Responsible Party):
Anthony A. Mikulec, MD, St. Louis University
ClinicalTrials.gov Identifier:
NCT02169830
First received: June 17, 2014
Last updated: November 30, 2016
Last verified: November 2016
  Purpose

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 Intervention
Migraine Disorders Drug: nortriptyline Drug: Topiramate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Cross-over Trial of Nortryptyline and Topiramate in the Initial Treatment of Vestibular Migraine.

Resource links provided by NLM:


Further study details as provided by Anthony A. Mikulec, MD, St. Louis University:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: June 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: nortriptyline
Diet modification - nortriptyline and then if necessary topiramate
Drug: nortriptyline
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
Drug: Topiramate
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Men and women aged 18 to 70 with untreated vestibular migraine variant as diagnosed by history.

Exclusion Criteria:

  • Patients with allergies to nortriptyline or topiramate and their analogs or medication interactions that preclude their use.
  • Patients under the care of a psychiatrist.
  • Patients who are pregnant or trying to become pregnant.
  • Patients taking more than 5 prescription medications.
  • Patients with cancer.
  • Patient has a history of immunodeficiency.
  • Patient has a history of substance abuse within the preceding 6 months prior to screening.
  • Patient has used an investigational drug or device in the the 3 months prior to screening.
  • Patient is using marijuana for medical or other uses.
  • Patient has any other clinically significant illness or medical condition that, in the investigator's opinion, would prohibit the subject from participating in the study.
  • Patient with traumatic brain injury.
  • Patients taking Nortriptyline, MAOIs
  • Patients with liver or kidney dysfunction or glaucoma

Due to know drug interactions, patients taking the following medications will be excluded.

Nortriptyline: monoamine oxidase inhibitors (MAO) such as phenelzine. Patients on oral contraceptives will be asked to use a secondary method as nortriptyline can reduce the effectiveness of oral contraceptives.

Topiramate: acetazolamide (kidney stones), digoxin

Exclude subjects with liver dysfunction, kidney dysfunction and glaucoma (per the risks associated with topiramate).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02169830

Contacts
Contact: Deniece D Webb, BA 314-268-7407 deniecewebb@slu.edu

Locations
United States, Missouri
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Deniece D Webb, BA    314-268-7407    deniecewebb@slu.edu   
Contact: Anthony Mikulec, MD    314-577-8884    mikuleca@slu.edu   
Principal Investigator: Anthony Mikulec, MD         
Sponsors and Collaborators
St. Louis University
Investigators
Principal Investigator: Anthony A Mikulec, MD St. Louis University
  More Information

Responsible Party: Anthony A. Mikulec, MD, Associate Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT02169830     History of Changes
Other Study ID Numbers: 24482_ Vest_Migraine
Study First Received: June 17, 2014
Last Updated: November 30, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Anthony A. Mikulec, MD, St. Louis University:
vestibular migraines, nortriptyline and topiramate

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Nortriptyline
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 23, 2017