Trial Outcomes & Findings for Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine (NCT NCT00846495)
NCT ID: NCT00846495
Last Updated: 2012-01-13
Results Overview
Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
55 participants
Primary outcome timeframe
Treatment Month 2
Results posted on
2012-01-13
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
COMPLETED
|
20
|
24
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine
Baseline characteristics by cohort
| Measure |
Topiramate
n=28 Participants
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
n=27 Participants
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
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
37.61 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
37.33 years
STANDARD_DEVIATION 9.46 • n=7 Participants
|
37.47 years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment Month 2Population: Number of Units Analyzed is equivalent to number of migraine attacks reported during 2nd Treatment Month.
Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2
Outcome measures
| Measure |
Topiramate
n=27 Migraine attacks
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
n=51 Migraine attacks
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.
|
|---|---|---|
|
Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate
|
1.35 Migraine attacks
Standard Deviation 1.31
|
2.12 Migraine attacks
Standard Deviation 1.75
|
PRIMARY outcome
Timeframe: Treatment Month 2Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine
Outcome measures
| Measure |
Topiramate
n=20 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine
|
4.75 Headache Days
Standard Deviation 2.59
|
2.79 Headache Days
Standard Deviation 3.26
|
SECONDARY outcome
Timeframe: 2 MonthsPopulation: Number of Units Analyzed is equivalent to number of headache days reported during Treatment Months 1 and 2.
Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication
Outcome measures
| Measure |
Topiramate
n=119 Headache Days
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
n=177 Headache Days
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.
|
|---|---|---|
|
Number of Headache Days Each Month Following Initiation of Treatment With Study Medication
Treatment Month 1
|
4.20 Headache Days
Standard Deviation 2.88
|
3.96 Headache Days
Standard Deviation 2.84
|
|
Number of Headache Days Each Month Following Initiation of Treatment With Study Medication
Treatment Month 2
|
1.75 Headache Days
Standard Deviation 1.86
|
3.42 Headache Days
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: 2 MonthsCompare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2
Outcome measures
| Measure |
Topiramate
n=20 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm
Migraine Attacks Treatment Month 1
|
11 Participants
|
13 Participants
|
|
Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm
Headache Days Treatment Month 1
|
7 Participants
|
9 Participants
|
|
Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm
Migraine Attacks Treatment Month 2
|
15 Participants
|
15 Participants
|
|
Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm
Headache Days Treatment Month 2
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Randomization, End of Treatment Month 1, End of Treatment Month 2Quality 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.
Outcome measures
| Measure |
Topiramate
n=20 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Quality of Life in Subjects Utilizing Each Treatment Paradigm
Role Function Restrictive - Baseline
|
56.00 Score on a Scale
Standard Deviation 15.88
|
59.88 Score on a Scale
Standard Deviation 16.65
|
|
Quality of Life in Subjects Utilizing Each Treatment Paradigm
Role Function Restrictive - Treatment Month 1
|
80.29 Score on a Scale
Standard Deviation 19.33
|
66.48 Score on a Scale
Standard Deviation 18.75
|
|
Quality of Life in Subjects Utilizing Each Treatment Paradigm
Role Function Restrictive - Treatment Month 2
|
86.64 Score on a Scale
Standard Deviation 13.98
|
71.84 Score on a Scale
Standard Deviation 19.57
|
|
Quality of Life in Subjects Utilizing Each Treatment Paradigm
Role Function Preventive - Baseline
|
77.75 Score on a Scale
Standard Deviation 16.02
|
77.50 Score on a Scale
Standard Deviation 18.53
|
|
Quality of Life in Subjects Utilizing Each Treatment Paradigm
Role Function Preventive - Treatment Month 1
|
85.25 Score on a Scale
Standard Deviation 18.32
|
79.25 Score on a Scale
Standard Deviation 21.96
|
|
Quality of Life in Subjects Utilizing Each Treatment Paradigm
Role Function Preventive - Treatment Month 2
|
93.95 Score on a Scale
Standard Deviation 7.57
|
84.96 Score on a Scale
Standard Deviation 16.67
|
|
Quality of Life in Subjects Utilizing Each Treatment Paradigm
Emotional Function - Baseline
|
60.67 Score on a Scale
Standard Deviation 22.47
|
64.71 Score on a Scale
Standard Deviation 23.13
|
|
Quality of Life in Subjects Utilizing Each Treatment Paradigm
Emotional Function - Treatment Month 1
|
80.00 Score on a Scale
Standard Deviation 25.68
|
73.18 Score on a Scale
Standard Deviation 21.59
|
|
Quality of Life in Subjects Utilizing Each Treatment Paradigm
Emotional Function - Treatment Month 2
|
91.46 Score on a Scale
Standard Deviation 10.49
|
75.10 Score on a Scale
Standard Deviation 24.04
|
SECONDARY outcome
Timeframe: Treatment Month 2Participant 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.
Outcome measures
| Measure |
Topiramate
n=20 Participants
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
n=24 Participants
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 Satisfaction With Study Medications
Efficacy
|
76.7857 Score on a Scale
Standard Deviation 21.04
|
75.1977 Score on a Scale
Standard Deviation 30.21
|
|
Participant Satisfaction With Study Medications
Functionality
|
77.8214 Score on a Scale
Standard Deviation 22.68
|
76.3648 Score on a Scale
Standard Deviation 29.98
|
|
Participant Satisfaction With Study Medications
Ease of Use
|
91.6607 Score on a Scale
Standard Deviation 11.5639
|
92.6989 Score on a Scale
Standard Deviation 11.36
|
|
Participant Satisfaction With Study Medications
Cost
|
81.2536 Score on a Scale
Standard Deviation 19.85
|
59.0886 Score on a Scale
Standard Deviation 32.86
|
|
Participant Satisfaction With Study Medications
Bothersomeness of Side Effects
|
95.1786 Score on a Scale
Standard Deviation 6.08
|
95.5398 Score on a Scale
Standard Deviation 6.81
|
|
Participant Satisfaction With Study Medications
Total Score
|
82.0925 Score on a Scale
Standard Deviation 15.77
|
81.1417 Score on a Scale
Standard Deviation 21.76
|
SECONDARY outcome
Timeframe: Treatment Months 1 and 2Includes Adverse Events at or above 5% frequency per group.
Outcome measures
| Measure |
Topiramate
n=45 Adverse Events
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
n=43 Adverse Events
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.
|
|---|---|---|
|
Adverse Events Associated With Study Medications
|
26 Adverse Events
|
11 Adverse Events
|
SECONDARY outcome
Timeframe: Treatment Months 1 and 2Average cost of study medication taken by each subject. Measured in dollars.
Outcome measures
| Measure |
Topiramate
n=20 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine
Preventive Medication Taken
|
343.56 Dollars (US)
Standard Deviation 50.4774
|
101.41 Dollars (US)
Standard Deviation 10.304
|
|
Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine
Rescue Medication Taken
|
38.33 Dollars (US)
Standard Deviation 10.45
|
59.94 Dollars (US)
Standard Deviation 9.54
|
|
Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine
All Study Medication Taken
|
381.89 Dollars (US)
Standard Deviation 51.8816
|
161.35 Dollars (US)
Standard Deviation 70.1844
|
Adverse Events
Topiramate
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Frovatriptan
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Topiramate
n=28 participants at risk
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
n=27 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
10.7%
3/28 • Number of events 3
|
0.00%
0/27
|
|
General disorders
Cold Symptoms
|
0.00%
0/28
|
7.4%
2/27 • Number of events 2
|
|
General disorders
Concentration Problems
|
10.7%
3/28 • Number of events 3
|
0.00%
0/27
|
|
Psychiatric disorders
Depression
|
7.1%
2/28 • Number of events 2
|
0.00%
0/27
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/28
|
7.4%
2/27 • Number of events 3
|
|
General disorders
Dizziness
|
3.6%
1/28 • Number of events 1
|
7.4%
2/27 • Number of events 3
|
|
General disorders
Irritability
|
7.1%
2/28 • Number of events 2
|
0.00%
0/27
|
|
General disorders
Memory Problems
|
7.1%
2/28 • Number of events 2
|
0.00%
0/27
|
|
Gastrointestinal disorders
Nausea
|
7.1%
2/28 • Number of events 2
|
7.4%
2/27 • Number of events 3
|
|
Nervous system disorders
Numbness in Extremities
|
7.1%
2/28 • Number of events 2
|
0.00%
0/27
|
|
Gastrointestinal disorders
Stomach Flu
|
7.1%
2/28 • Number of events 2
|
0.00%
0/27
|
|
General disorders
Taste Aversion
|
10.7%
3/28 • Number of events 3
|
0.00%
0/27
|
|
Nervous system disorders
Tingling in Extremities
|
10.7%
3/28 • Number of events 4
|
0.00%
0/27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place