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Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine

A Randomized, Single-Blind Pilot Study to Compare the Efficacy and Cost-Effectiveness of Frovatriptan vs. Topiramate for the Prevention of Migraine

NCT00846495•Clinvest

View on ClinicalTrials.gov

Summary

Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit 3.This study will compare the effectiveness of daily treatment vs. treatment during the pre-headache phase for prevention of migraine.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subject has at least a one-year history of migraine with or without aura meeting International Headache Society criteria (see Appendix)
•2. Subject has a 3-month history of averaging 3-6 migraines per month
•3. Subject reports premonitory symptoms and the ability to predict at least 50% of high impact headaches
•4. Subjects must currently or have in the past successfully utilized a triptan as an acute treatment for migraine as determined by the investigator.
•5. Male or female at least 18 years of age
•6. Subject of childbearing potential agrees to use adequate contraception during the study. Adequate methods of contraception are to be determined by the investigator and should be consistent with contraceptive care administered in the regular clinical use of frovatriptan and topiramate.
•7. Subject is aware of prodrome symptoms that may include physiological, psychological or cognitive changes. These may include, but are not limited to such symptoms as Pre-Menstrual Syndrome (PMS), change in mood, energy level, appetite, food craving, nausea, sense of hearing, sense of smell or swelling/fluid retention, excessive yawning, head pain, muscle pain/tenderness, irritability, confusion, extreme sleepiness, impaired speech or impaired memory. (The subject should be able to differentiate these symptoms from other similar symptoms that do not precede migraine). The symptoms should precede migraine by 4-24 hours signaling an impending migraine attack.
•8. Subject is able to understand instructions for the study and complete the diary
•9. Subject is willing to give informed consent to participate in the study
•10. Any migraine prophylactic medication must have a stabilized dosage for one month

Exclusion Criteria

•1. History of any medical condition that would confound the results of the study including but not limited to the following:
•* Hepatic disease or significant hepatic dysfunction
•* History of pancreatitis
•* History of thrombocytopenia
•* History of glaucoma
•* History of osteoporosis or osteopenia
•* Cardiovascular Disease - Coronary artery disease, Ischemic heart disease or Significant Arrhythmia
•* History of active Cerebrovascular Disease
•* Hypertension - Uncontrolled hypertension in a non-migrainous state (\> 160 mmHg systolic or \>95 mmHg. diastolic). Hypertension must be controlled effectively with medication for a period of 3 months.
•* Basilar or Hemiplegic Migraine
+13 more criteria

Locations (2)

Physician Associates LLC

Oviedo, Florida, United States

Clinvest

Springfield, Missouri, United States

Key Dates

Start Date

August 1, 2009

Primary Completion Date

January 1, 2011

Completion Date

January 1, 2011

Last Updated

January 13, 2012

Enrollment

ACTUAL participants

Conditions

Migraine

Interventions

topiramate

DRUG

frovatriptan

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

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Mind Body Balance for Pediatric Migraine

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