Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine
This study has been completed.
Sponsor:
Clinvest
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Clinvest, Cady, Roger, M.D.
ClinicalTrials.gov Identifier:
NCT00846495
First received: February 17, 2009
Last updated: January 11, 2012
Last verified: January 2012
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Results First Received: June 9, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Prevention |
| Condition: |
Migraine |
| Interventions: |
Drug: topiramate Drug: frovatriptan |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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Reporting Groups
| Description | |
|---|---|
| Topiramate | 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. |
| Frovatriptan | 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. |
Participant Flow: Overall Study
| Topiramate | Frovatriptan | |
|---|---|---|
| STARTED | 28 | 27 |
| COMPLETED | 20 | 24 |
| NOT COMPLETED | 8 | 3 |
| Lost to Follow-up | 1 | 0 |
| Adverse Event | 5 | 1 |
| Lack of Efficacy | 1 | 2 |
| Physician Decision | 1 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Topiramate | 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. |
| Frovatriptan | 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 | Total of all reporting groups |
Baseline Measures
| Topiramate | Frovatriptan | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
28 | 27 | 55 |
|
Age
[units: participants] |
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| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 28 | 27 | 55 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
37.61 ± 10.3 | 37.33 ± 9.46 | 37.47 ± 9.82 |
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Gender
[units: participants] |
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| Female | 22 | 21 | 43 |
| Male | 6 | 6 | 12 |
|
Region of Enrollment
[units: participants] |
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| United States | 28 | 27 | 55 |
Outcome Measures
| 1. Primary: | Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate [ Time Frame: Treatment Month 2 ] |
| 2. Primary: | Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine [ Time Frame: Treatment Month 2 ] |
| 3. Secondary: | Number of Headache Days Each Month Following Initiation of Treatment With Study Medication [ Time Frame: 2 Months ] |
| 4. Secondary: | Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm [ Time Frame: 2 Months ] |
| 5. Secondary: | Quality of Life in Subjects Utilizing Each Treatment Paradigm [ Time Frame: Randomization, End of Treatment Month 1, End of Treatment Month 2 ] |
| 6. Secondary: | Participant Satisfaction With Study Medications [ Time Frame: Treatment Month 2 ] |
| 7. Secondary: | Adverse Events Associated With Study Medications [ Time Frame: Treatment Months 1 and 2 ] |
| 8. Secondary: | Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine [ Time Frame: Treatment Months 1 and 2 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
Publications:
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |
Results Point of Contact:
Name/Title: Rebecca Browning
Organization: Clinvest
phone: 417-841-3664
e-mail: rbrowning@clinvest.com
Organization: Clinvest
phone: 417-841-3664
e-mail: rbrowning@clinvest.com
Publications:
| Responsible Party: | Clinvest, 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 |