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

This study has been completed.
Sponsor:
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
History of Changes
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
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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  
Number of Participants  
[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 ]
  Show Outcome Measure 8


  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:


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