Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine

NCT ID: NCT03280342

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2018-09-13

Brief Summary

Crossover, randomized, double blind: Q12h dosing in both periods; matching placebo for evening dosing during XR treatment; target dose: 100mg

Detailed Description

The primary objective is to compare the effect of treatment with an immediate-release topiramate (IR-TPM), namely Topamax®, to an extended-release topiramate (XR-TPM), namely Trokendi XR®, regimen on cognition in adults with migraine.

The secondary objective is to determine the factors that explain inter-individual variability in cognitive response. Pharmacokinetic and demographic factors will be explored. Variability in cognitive response between individuals can be large. A population approach (nonlinear, mixed effects) will be used to determine drug exposure response relationships.

Conditions

Migraine; Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IR-TPM (Topamax)

IR-TPM (Topamax)

Group Type: ACTIVE_COMPARATOR

IR-TPM (Topamax)

Intervention Type: DRUG

XR-TPM (Trokendi XR)

XR-TPM (Trokendi XR)

Intervention Type: DRUG

XR-TPM (Trokendi XR)

XR-TPM (Trokendi XR)

Group Type: ACTIVE_COMPARATOR

IR-TPM (Topamax)

Intervention Type: DRUG

XR-TPM (Trokendi XR)

XR-TPM (Trokendi XR)

Intervention Type: DRUG

XR-TPM (Trokendi XR)

Interventions

IR-TPM (Topamax)

XR-TPM (Trokendi XR)

Intervention Type: DRUG

XR-TPM (Trokendi XR)

XR-TPM (Trokendi XR)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Established history of episodic migraine with or without aura, as assessed by International Headache Society criteria, for at least 6 months before screening and frequency of 3 or more headache attacks per month during the past 3 months

2. Male or female, ages 18-65

3. Women are required to be postmenopausal, surgically incapable of bearing children, or practicing a medically acceptable method of birth control (i.e., double barrier method, IUD, Mirena, etc) for at least 1 month before study entry through 30 days following last dose.

4. If postmenopausal and on hormone replacement therapy (HRT) then must to be on a stable regimen for at least 2 months (continuous stable regimen of cyclic or non-cyclic HRT); negative pregnancy test.

5. Native English speakers (due to speech and language analysis)

6. Montreal Cognitive Assessment (MoCA) score equal to or greater than 26.

Exclusion Criteria

1. Onset of migraine occurred after age 50 years, or overuse of analgesics or migraine specific agents for the acute treatment of migraine episodes; examples of analgesic overuse included the following: more than 8 treatment episodes (episode defined as any calendar day of usage) of ergot containing medications a month; more than 8 treatment episodes of triptans a month; or more than 6 treatment episodes of potent opioids a month.

2. Required, continued use of the following medications for any medical reason during the study: beta-blockers, benzodiazepines, tricyclic antidepressants, antiepileptics, calcium channel blockers, monoamine oxidase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs) daily, opioids, agents for insomnia (e.g., Ambien, diphenhydramine-containing OTC products); corticosteroids, local anesthetics, botulinum toxin within last three months, or herbal preparations such as feverfew or St John's wort. However, subjects will be permitted to be on a stable regimen of a selective serotonin reuptake inhibitor or SNRI for 3 months or more for depression and/or anxiety.

3. A history of nephrolithiasis

4. Have previously taken topiramate

5. Received an experimental drug or used an experimental or approved device for migraine prevention (e.g., TENIS unit) within 30 days of screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Marino, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Prism Research

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

FWA00000312-10

Identifier Type: -

Identifier Source: org_study_id