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| Name | Class |
|---|---|
| Endo USA Inc., a Keenova Therapeutics Company | INDUSTRY |
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Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit 3.This study will compare the effectiveness of daily treatment vs. treatment during the pre-headache phase for prevention of migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topiramate | Active Comparator | Subjects randomized to Group A at Visit 2 were provided with topiramate, titrated over 4 weeks to a maximum dose of 100 mg daily. One dosage adjustment was allowed with a minimum dose of 50 mg daily. |
|
| frovatriptan | Active Comparator | Subjects randomized to Group B at Visit 2 were provided with frovatriptan 5 mg to treat during prodrome at the point they were confident a disabling migraine would occur (before the onset of headache). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topiramate | Drug | topiramate 25mg 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 2 tabs in PM x 1 week topiramate 25mg 2 tabs in AM / 2 tabs in PM x 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate | Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2 | Treatment Month 2 |
| Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine | Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine | Treatment Month 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Headache Days Each Month Following Initiation of Treatment With Study Medication | Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication | 2 Months |
| Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
History of any medical condition that would confound the results of the study including but not limited to the following:
History of ergotamine, "triptan", or analgesic abuse within past 3 months
History of current or recent drug or alcohol abuse that would interfere with participation in the study.
More than 15 headache days per month within past 3 months.
Women who are pregnant or breast feeding
Subjects with known hypersensitivity or intolerance to topiramate or any triptan-like medication
Subject is scheduled for surgical procedure to occur while enrolled in study.that in opinion of the Investigator would interfere with participation in the study.
Subject is on a ketogenic diet
Participation in another investigative drug study within the previous 30 days
Excluded medications: MAO Inhibitors, lithium, methylergonovine, methysergide, ergotamine-containing products, or topiramate daily for migraine prophylaxis.
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| Name | Affiliation | Role |
|---|---|---|
| Roger K Cady, MD | Clinvest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physician Associates LLC | Oviedo | Florida | 32765 | United States | ||
| Clinvest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10961768 | Background | 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. doi: 10.1046/j.1468-2982.2000.00030.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate | Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2 | Number of Units Analyzed is equivalent to number of migraine attacks reported during 2nd Treatment Month. | Posted | Mean | Standard Deviation | Migraine attacks | Treatment Month 2 | Migraine attacks | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Browning | Clinvest | 417-841-3664 | rbrowning@clinvest.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| C108128 | frovatriptan |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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|
| frovatriptan | Drug | frovatriptan 5mg tab during premonitory phase of migraine |
|
|
Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2 |
| 2 Months |
| Quality of Life in Subjects Utilizing Each Treatment Paradigm | 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. | Randomization, End of Treatment Month 1, End of Treatment Month 2 |
| Participant Satisfaction With Study Medications | 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. | Treatment Month 2 |
| Adverse Events Associated With Study Medications | Includes Adverse Events at or above 5% frequency per group. | Treatment Months 1 and 2 |
| Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine | Average cost of study medication taken by each subject. Measured in dollars. | Treatment Months 1 and 2 |
| Springfield |
| Missouri |
| 65807 |
| United States |
| Lack of Efficacy |
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| Physician Decision |
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Primary | Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine | Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine | Posted | Mean | Standard Deviation | Headache Days | Treatment Month 2 |
|
|
|
| Secondary | Number of Headache Days Each Month Following Initiation of Treatment With Study Medication | Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication | Number of Units Analyzed is equivalent to number of headache days reported during Treatment Months 1 and 2. | Posted | Mean | Standard Deviation | Headache Days | 2 Months | Headache Days | Participants |
|
|
|
| Secondary | Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm | Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2 | Posted | Number | Participants | 2 Months |
|
|
|
| Secondary | Quality of Life in Subjects Utilizing Each Treatment Paradigm | 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. | Posted | Mean | Standard Deviation | Score on a Scale | Randomization, End of Treatment Month 1, End of Treatment Month 2 |
|
|
|
| Secondary | Participant Satisfaction With Study Medications | 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. | Posted | Mean | Standard Deviation | Score on a Scale | Treatment Month 2 |
|
|
|
| Secondary | Adverse Events Associated With Study Medications | Includes Adverse Events at or above 5% frequency per group. | Posted | Number | Adverse Events | Treatment Months 1 and 2 | Adverse Events | Participants |
|
|
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| Secondary | Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine | Average cost of study medication taken by each subject. Measured in dollars. | Posted | Mean | Standard Deviation | Dollars (US) | Treatment Months 1 and 2 |
|
|
|
| 0 |
| 28 |
| 17 |
| 28 |
| EG001 | 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. | 0 | 27 | 5 | 27 |
| Cold Symptoms | General disorders | Systematic Assessment |
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| Concentration Problems | General disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Irritability | General disorders | Systematic Assessment |
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| Memory Problems | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Numbness in Extremities | Nervous system disorders | Systematic Assessment |
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| Stomach Flu | Gastrointestinal disorders | Systematic Assessment |
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| Taste Aversion | General disorders | Systematic Assessment |
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| Tingling in Extremities | Nervous system disorders | Systematic Assessment |
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| D009422 | Nervous System Diseases |
| Carbohydrates |
| D007661 | Ketoses |
| Migraine Attacks Treatment Month 2 |
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| Headache Days Treatment Month 2 |
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| Role Function Restrictive - Treatment Month 2 |
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| Role Function Preventive - Baseline |
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| Role Function Preventive - Treatment Month 1 |
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| Role Function Preventive - Treatment Month 2 |
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| Emotional Function - Baseline |
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| Emotional Function - Treatment Month 1 |
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| Emotional Function - Treatment Month 2 |
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| Ease of Use |
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| Cost |
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| Bothersomeness of Side Effects |
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| Total Score |
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| All Study Medication Taken |
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