Status:
WITHDRAWN
Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Supernus Pharmaceuticals, Inc.
Conditions:
Migraine
Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- Male or female, ages 18-65
- 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.
- 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.
- Native English speakers (due to speech and language analysis)
- Montreal Cognitive Assessment (MoCA) score equal to or greater than 26.
Exclusion
- 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.
- 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.
- A history of nephrolithiasis
- Have previously taken topiramate
- Received an experimental drug or used an experimental or approved device for migraine prevention (e.g., TENIS unit) within 30 days of screening
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03280342
Start Date
October 30 2017
End Date
September 13 2018
Last Update
November 1 2019
Active Locations (2)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
Prism Research
Saint Paul, Minnesota, United States, 55114