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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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Prevention |
Condition |
Migraine |
Interventions |
Drug: topiramate Drug: frovatriptan |
Enrollment | 55 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Topiramate | Frovatriptan |
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Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg. | Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome. |
Period Title: Overall Study | ||
Started | 28 | 27 |
Completed | 20 | 24 |
Not Completed | 8 | 3 |
Reason Not Completed | ||
Lost to Follow-up | 1 | 0 |
Adverse Event | 5 | 1 |
Lack of Efficacy | 1 | 2 |
Physician Decision | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Topiramate | Frovatriptan | Total | |
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Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg. | Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome. | Total of all reporting groups | |
Overall Number of Baseline Participants | 28 | 27 | 55 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 28 participants | 27 participants | 55 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
28 100.0%
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27 100.0%
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55 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 28 participants | 27 participants | 55 participants | |
37.61 (10.3) | 37.33 (9.46) | 37.47 (9.82) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 28 participants | 27 participants | 55 participants | |
Female |
22 78.6%
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21 77.8%
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43 78.2%
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Male |
6 21.4%
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6 22.2%
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12 21.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 28 participants | 27 participants | 55 participants |
28 | 27 | 55 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Rebecca Browning |
Organization: | Clinvest |
Phone: | 417-841-3664 |
EMail: | rbrowning@clinvest.com |
Responsible Party: | Clinvest, Cady, Roger, M.D. |
ClinicalTrials.gov Identifier: | NCT00846495 |
Other Study ID Numbers: |
Frova vs. Topiramate |
First Submitted: | February 17, 2009 |
First Posted: | February 18, 2009 |
Results First Submitted: | June 9, 2011 |
Results First Posted: | August 9, 2011 |
Last Update Posted: | January 13, 2012 |