Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine
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ClinicalTrials.gov Identifier: NCT00846495 |
Recruitment Status :
Completed
First Posted : February 18, 2009
Results First Posted : August 9, 2011
Last Update Posted : January 13, 2012
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Sponsor:
Clinvest
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Clinvest, Cady, Roger, M.D.
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Tracking Information | ||||
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First Submitted Date ICMJE | February 17, 2009 | |||
First Posted Date ICMJE | February 18, 2009 | |||
Results First Submitted Date ICMJE | June 9, 2011 | |||
Results First Posted Date ICMJE | August 9, 2011 | |||
Last Update Posted Date | January 13, 2012 | |||
Study Start Date ICMJE | August 2009 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine | |||
Official Title ICMJE | A Randomized, Single-Blind Pilot Study to Compare the Efficacy and Cost-Effectiveness of Frovatriptan vs. Topiramate for the Prevention of Migraine | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Migraine | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Luciani R, Carter D, Mannix L, Hemphill M, Diamond M, Cady R. Prevention of migraine during prodrome with naratriptan. Cephalalgia. 2000 Mar;20(2):122-6. doi: 10.1046/j.1468-2982.2000.00030.x. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
55 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Actual Study Completion Date ICMJE | January 2011 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | INCLUSION CRITERIA
EXCLUSION CRITERIA
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00846495 | |||
Other Study ID Numbers ICMJE | Frova vs. Topiramate | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Clinvest, Cady, Roger, M.D. | |||
Original Responsible Party | Roger K. Cady, MD, Clinvest | |||
Current Study Sponsor ICMJE | Clinvest | |||
Original Study Sponsor ICMJE | Cady, Roger, M.D. | |||
Collaborators ICMJE | Endo Pharmaceuticals | |||
Investigators ICMJE |
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PRS Account | Cady, Roger, M.D. | |||
Verification Date | January 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |