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| Sponsor: | Clinvest |
|---|---|
| Collaborator: |
Endo Pharmaceuticals |
| Information provided by (Responsible Party): | Clinvest, Cady, Roger, M.D. |
| ClinicalTrials.gov Identifier: | NCT00846495 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: topiramate Drug: frovatriptan |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | A Randomized, Single-Blind Pilot Study to Compare the Efficacy and Cost-Effectiveness of Frovatriptan vs. Topiramate for the Prevention of Migraine |
Participant satisfaction is measured by the Patient Perception of Migraine Questionnaire (PPMQ). Questions were categorized within 6 dimensions: Efficacy, Functionality, Ease of Use, Cost, Bothersomeness of Side Effects, and Total Score. Scores range from 0 to 100. Higher scores represent better satisfaction.
Participants completed the PPMQ 24 hours following each first dose of frovatriptan.
| Enrollment: | 55 |
| Study Start Date: | August 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: topiramate
Subjects randomized to Group A at Visit 2 were provided with topiramate, titrated over 4 weeks to a maximum dose of 100 mg daily. One dosage adjustment was allowed with a minimum dose of 50 mg daily.
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Drug: topiramate
topiramate 25mg 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 2 tabs in PM x 1 week topiramate 25mg 2 tabs in AM / 2 tabs in PM x 5 weeks
Other Name: Topamax
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Active Comparator: frovatriptan
Subjects randomized to Group B at Visit 2 were provided with frovatriptan 5 mg to treat during prodrome at the point they were confident a disabling migraine would occur (before the onset of headache).
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Drug: frovatriptan
frovatriptan 5mg tab during premonitory phase of migraine
Other Name: Frova
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA
EXCLUSION CRITERIA
History of any medical condition that would confound the results of the study including but not limited to the following:
Contacts and Locations| United States, Florida | |
| Physician Associates LLC | |
| Oviedo, Florida, United States, 32765 | |
| United States, Missouri | |
| Clinvest | |
| Springfield, Missouri, United States, 65807 | |
| Principal Investigator: | Roger K Cady, MD | Clinvest |
More Information
| Responsible Party: | Clinvest, CEO, Cady, Roger, M.D. |
| ClinicalTrials.gov Identifier: | NCT00846495 History of Changes |
| Other Study ID Numbers: | Frova vs. Topiramate |
| Study First Received: | February 17, 2009 |
| Results First Received: | June 9, 2011 |
| Last Updated: | January 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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Migraine Migraine prevention Prodrome Premonitory phase Preemptive therapy |
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Topiramate Frovatriptan Anticonvulsants Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |