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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00846495
Recruitment Status : Completed
First Posted : February 18, 2009
Results First Posted : August 9, 2011
Last Update Posted : January 13, 2012
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Clinvest, Cady, Roger, M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Condition Migraine
Interventions Drug: topiramate
Drug: frovatriptan
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topiramate Frovatriptan
Hide Arm/Group Description 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
Arm/Group Title Topiramate Frovatriptan Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
27
 100.0%
55
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 28 participants 27 participants 55 participants
Female
22
  78.6%
21
  77.8%
43
  78.2%
Male
6
  21.4%
6
  22.2%
12
  21.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 27 participants 55 participants
28 27 55
1.Primary Outcome
Title Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate
Hide Description Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2
Time Frame Treatment Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Units Analyzed is equivalent to number of migraine attacks reported during 2nd Treatment Month.
Arm/Group Title Topiramate Frovatriptan
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20 24
Overall Number of Units Analyzed
Type of Units Analyzed: Migraine attacks
 27 51
Mean (Standard Deviation)
Unit of Measure: Migraine attacks
1.35  (1.31) 2.12  (1.75)
2.Primary Outcome
Title Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine
Hide Description Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine
Time Frame Treatment Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topiramate Frovatriptan
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20 24
Mean (Standard Deviation)
Unit of Measure: Headache Days
4.75  (2.59) 2.79  (3.26)
3.Secondary Outcome
Title Number of Headache Days Each Month Following Initiation of Treatment With Study Medication
Hide Description Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication
Time Frame 2 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Units Analyzed is equivalent to number of headache days reported during Treatment Months 1 and 2.
Arm/Group Title Topiramate Frovatriptan
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20 24
Overall Number of Units Analyzed
Type of Units Analyzed: Headache Days
 119 177
Mean (Standard Deviation)
Unit of Measure: Headache Days
Treatment Month 1 4.20  (2.88) 3.96  (2.84)
Treatment Month 2 1.75  (1.86) 3.42  (2.98)
4.Secondary Outcome
Title Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm
Hide Description Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2
Time Frame 2 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topiramate Frovatriptan
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20 24
Measure Type: Number
Unit of Measure: Participants
Migraine Attacks Treatment Month 1 11 13
Headache Days Treatment Month 1 7 9
Migraine Attacks Treatment Month 2 15 15
Headache Days Treatment Month 2 16 13
5.Secondary Outcome
Title Quality of Life in Subjects Utilizing Each Treatment Paradigm
Hide Description Quality of Life is measured by the Migraine Specific Quality of Life Questionnaire (MSQ), which includes 3 dimensions: Role Function Restrictive (degree to which performance of daily activities is limited), Role Function Preventive (degree to which performance of daily activities is interrupted), and Emotional Function (frustration and helplessness due to migraine). Scores range from 0 to 100. For each dimension, a higher score indicates a better health status. Participants completed the MSQ at Randomization, and after Treatment Months 1 and 2.
Time Frame Randomization, End of Treatment Month 1, End of Treatment Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topiramate Frovatriptan
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20 24
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Role Function Restrictive - Baseline 56.00  (15.88) 59.88  (16.65)
Role Function Restrictive - Treatment Month 1 80.29  (19.33) 66.48  (18.75)
Role Function Restrictive - Treatment Month 2 86.64  (13.98) 71.84  (19.57)
Role Function Preventive - Baseline 77.75  (16.02) 77.50  (18.53)
Role Function Preventive - Treatment Month 1 85.25  (18.32) 79.25  (21.96)
Role Function Preventive - Treatment Month 2 93.95  (7.57) 84.96  (16.67)
Emotional Function - Baseline 60.67  (22.47) 64.71  (23.13)
Emotional Function - Treatment Month 1 80.00  (25.68) 73.18  (21.59)
Emotional Function - Treatment Month 2 91.46  (10.49) 75.10  (24.04)
6.Secondary Outcome
Title Participant Satisfaction With Study Medications
Hide Description

Participant satisfaction is measured by the Patient Perception of Migraine Questionnaire (PPMQ). Questions were categorized within 6 dimensions: Efficacy, Functionality, Ease of Use, Cost, Bothersomeness of Side Effects, and Total Score. Scores range from 0 to 100. Higher scores represent better satisfaction.

Participants completed the PPMQ 24 hours following each first dose of frovatriptan.
Time Frame Treatment Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topiramate Frovatriptan
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20 24
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Efficacy 76.7857  (21.04) 75.1977  (30.21)
Functionality 77.8214  (22.68) 76.3648  (29.98)
Ease of Use 91.6607  (11.5639) 92.6989  (11.36)
Cost 81.2536  (19.85) 59.0886  (32.86)
Bothersomeness of Side Effects 95.1786  (6.08) 95.5398  (6.81)
Total Score 82.0925  (15.77) 81.1417  (21.76)
7.Secondary Outcome
Title Adverse Events Associated With Study Medications
Hide Description Includes Adverse Events at or above 5% frequency per group.
Time Frame Treatment Months 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topiramate Frovatriptan
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20 24
Overall Number of Units Analyzed
Type of Units Analyzed: Adverse Events
 45 43
Measure Type: Number
Unit of Measure: Adverse Events
26 11
8.Secondary Outcome
Title Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine
Hide Description Average cost of study medication taken by each subject. Measured in dollars.
Time Frame Treatment Months 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topiramate Frovatriptan
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20 24
Mean (Standard Deviation)
Unit of Measure: Dollars (US)
Preventive Medication Taken 343.56  (50.4774) 101.41  (10.304)
Rescue Medication Taken 38.33  (10.45) 59.94  (9.54)
All Study Medication Taken 381.89  (51.8816) 161.35  (70.1844)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topiramate Frovatriptan
Hide Arm/Group Description 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.
All-Cause Mortality
Topiramate Frovatriptan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Topiramate Frovatriptan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/27 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Topiramate Frovatriptan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/28 (60.71%)      5/27 (18.52%)    
Gastrointestinal disorders     
Diarrhea †  0/28 (0.00%)  0 2/27 (7.41%)  3
Nausea †  2/28 (7.14%)  2 2/27 (7.41%)  3
Stomach Flu †  2/28 (7.14%)  2 0/27 (0.00%)  0
General disorders     
Cold Symptoms †  0/28 (0.00%)  0 2/27 (7.41%)  2
Concentration Problems †  3/28 (10.71%)  3 0/27 (0.00%)  0
Dizziness †  1/28 (3.57%)  1 2/27 (7.41%)  3
Irritability †  2/28 (7.14%)  2 0/27 (0.00%)  0
Memory Problems †  2/28 (7.14%)  2 0/27 (0.00%)  0
Taste Aversion †  3/28 (10.71%)  3 0/27 (0.00%)  0
Nervous system disorders     
Numbness in Extremities †  2/28 (7.14%)  2 0/27 (0.00%)  0
Tingling in Extremities †  3/28 (10.71%)  4 0/27 (0.00%)  0
Psychiatric disorders     
Anxiety †  3/28 (10.71%)  3 0/27 (0.00%)  0
Depression †  2/28 (7.14%)  2 0/27 (0.00%)  0
†
Indicates events were collected by systematic assessment
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Rebecca Browning
Organization: Clinvest
Phone: 417-841-3664
EMail: rbrowning@clinvest.com
Publications:
Layout table for additonal information
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