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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Prevention
Condition:	Migraine
Interventions:	Drug: topiramate; Drug: frovatriptan

  Participant Flow

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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

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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.
Total	Total of all reporting groups

Baseline Measures

	Topiramate	Frovatriptan	Total
Overall Participants Analyzed; [Units: Participants]	28	27	55
Age; [Units: Participants]
<=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)
Gender; [Units: Participants]
Female	22	21	43
Male	6	6	12
Region of Enrollment; [Units: Participants]
United States	28	27	55

  Outcome Measures

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1. Primary:

Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate [ Time Frame: Treatment Month 2 ]

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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 ]

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3. Secondary:

Number of Headache Days Each Month Following Initiation of Treatment With Study Medication [ Time Frame: 2 Months ]

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4. Secondary:

Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm [ Time Frame: 2 Months ]

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5. Secondary:

Quality of Life in Subjects Utilizing Each Treatment Paradigm [ Time Frame: Randomization, End of Treatment Month 1, End of Treatment Month 2 ]

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6. Secondary:

Participant Satisfaction With Study Medications [ Time Frame: Treatment Month 2 ]

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7. Secondary:

Adverse Events Associated With Study Medications [ Time Frame: Treatment Months 1 and 2 ]

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8. Secondary:

Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine [ Time Frame: Treatment Months 1 and 2 ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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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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  More Information

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Certain Agreements:  

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.

Results Point of Contact:  

Name/Title: Rebecca Browning
Organization: Clinvest
phone: 417-841-3664
e-mail: rbrowning@clinvest.com

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.

Responsible Party:	Clinvest, Cady, Roger, M.D.
ClinicalTrials.gov Identifier:	NCT00846495 History of Changes
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