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

NCT02169830 | Terminated Results DMC

• 1 other identifier: 24482_ Vest_Migraine
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Keywords

vestibular migraines, nortriptyline and topiramate

Outcome Measures

Primary Outcomes (1)

• Evaluate the Comparative Effectiveness of Migraine Diet, Nortriptyline and Topiramate

  Changes in Migraine Specific Quality of LIfe (MSQ) and Dizziness Handicap Inventory (DHI) between groups

  one year

Study Arms (3)

nortriptyline

ACTIVE COMPARATOR

If after four (4) weeks of diet modification, patients are still experiencing migraines, they may be randomized to nortriptyline for eight (8) weeks. If still experiencing symptoms, they will receive topiramate for eight (8) weeks.

Drug: nortriptyline

topiramate

ACTIVE COMPARATOR

If after four (4) weeks of diet modification, patients are still experiencing migraines, they may be randomized to topiramate for eight (8) weeks. If still experiencing symptoms, they will receive nortriptyline for eight (8) weeks.

Drug: Topiramate

diet modification

OTHER

Participants will begin with diet modification for four (4) weeks.

Behavioral: Diet Modification

Interventions

nortriptyline DRUG

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.

Also known as: Nortriptyline HCI

nortriptyline

Topiramate DRUG

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

Also known as: Topamax

topiramate

Diet Modification BEHAVIORAL

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.

diet modification

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Nortriptyline; Topiramate; Diet Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Nutrition Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Anthony A Mikulec
• Organization: Saint Louis University

anthony.mikulec@health.slu.edu

314-977-8884

Study Officials

• Anthony A Mikulec, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 23, 2014
• Study Start: August 22, 2014
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: April 23, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-03

Locations

US (1)