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| ID | Type | Description | Link |
|---|---|---|---|
| MIG-KOR-001 |
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The purpose of this study is to investigate the adequacy (reasonably good) of topiramate therapy (medicine or medical care given to a participant for a disease or condition) in prevention of migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or diarrhea) by comparing standard titration (slow increase in drug dosage, guided by patient's responses) therapy to slow titration therapy and slow titration therapy boosted by the concurrent use of propranolol in participants with migraine with or without aura (having to do with the ear) for more than or equal to 2 attacks per month.
This is a prospective (study following participants forward in time), single-blind (Physician does not know the intervention), randomized (study drug assigned by chance) and comparative multi-center (conducted in more than 1 center) study to assess appropriate administration methods with topiramate preventive therapy in participants with migraine. The study consists of 3 periods: Screening period (4 weeks), Treatment period consisting of 2 titration periods (3 weeks each) and Maintenance period (4 weeks). During Screening period, after the diagnosis of participants' headache, symptoms and severity of migraine will be investigated through a headache diary and participants will be selected for treatment period. In the treatment period, the selected participants will be randomly assigned to either of the 3 topiramate therapy: 'topiramate standard group', 'topiramate slow group', and 'topiramate slow plus propranolol (booster) group'. In the 'topiramate standard group' - participants will receive an initial dose of topiramate 25 milligram (mg) once daily and the dose of topiramate will be increased by 25 mg per day at an interval of 1-week up to the target dose of 50 mg to 100 mg up to Week 6; and a maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. In 'topiramate slow group' - participants will start with an initial dose of 25 mg once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. In 'topiramate slow plus propranolol (booster) group' - participants will follow the same dosage regimen as in the 'topiramate slow group' along with concurrent administration of booster dose of propranolol 80 mg once daily (40 mg each time in the morning and in the evening) for 6 weeks. The participants will primarily be evaluated for reduction in migraine frequency between Week 7 and 10 using a headache diary questionnaire maintained by them. Participants' quality of life will be assessed using Migraine Disability Assessment (MIDAS) score and intensity of pain in migraine will be assessed using Visual Analogue Scale (VAS). Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate Standard | Experimental | Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. |
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| Topiramate Slow | Experimental | Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. |
|
| Topiramate Slow and Propranolol Booster | Experimental | Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg will be administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate Standard | Drug | Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Decrease in Migraine Episodes | Decrease in percentage of migraine frequency (episodes) was measured from baseline using a headache diary which is a typical scale measuring neuropsychiatric symptoms in a migraine participant. Migraine will be diagnosed in accordance with the guidelines of the International Headache Society (IHS). | Maintenance period (Weeks 7 to 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Migraine Frequency at Week 6 | The migraine frequency at Week 6 was evaluated through a headache diary completed by a participant and the reduction rate of migraine frequency compared to the Baseline period was measured. Change values were calculated as Baseline value minus value at Week 6. | Baseline and Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Busan | South Korea | |||||
Out of 250 consented participants, 243 participants were assigned to study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Topiramate Standard | Topiramate 25 milligram (mg) was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. |
| FG001 | Topiramate Slow | Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. |
| FG002 | Topiramate Slow and Propranolol Booster | Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline characteristics were measured for Intent-to-treat (ITT) population which was defined as participants who took topiramate at least once and had migraine improvement data at the Week 6.
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| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate Standard | Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age, Customized was measured for ITT population which was defined as participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'N=239' (80, 82, and 78 for topiramate standard, topiramate slow, topiramate slow and propranolol booster groups respectively) signifies the participants who were evaluated for this Baseline characteristic. |
| 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 | Percentage Decrease in Migraine Episodes | Decrease in percentage of migraine frequency (episodes) was measured from baseline using a headache diary which is a typical scale measuring neuropsychiatric symptoms in a migraine participant. Migraine will be diagnosed in accordance with the guidelines of the International Headache Society (IHS). | The intent-to-treat (ITT) population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'N' signifies participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Percentage decrease in migraine episodes | Maintenance period (Weeks 7 to 10) |
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Baseline up to Week 10
Participants evaluable for safety were 81, 83, and 79 for topiramate standard, topiramate slow, topiramate slow and propranolol booster groups respectively.
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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 Standard | Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paresthesia | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Associate | Medical Affairs / Janssen-Cil Korea | 82-2-2094-4837 |
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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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| Topiramate Slow | Drug | Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. |
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| Propranolol booster | Drug | Propranolol 80 mg will be administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6. |
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| Change From Baseline in Migraine Disability Assessment (MIDAS) Score at Week 6 |
MIDAS scoring ranges from 0 to 63. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability). Change values were calculated as Baseline value minus value at Week 6. |
| Baseline and Week 6 |
| Change From Baseline in Visual Analogue Scale (VAS) Score at Week 6 | VAS was used to measure the intensity of migraine. The assessment scale ranges from 0 to 10. One end of the line drawn on the questionnaire is marked with 0 point indicating "no headache" and the other end with 10 points indicating "unimaginably strong headache." It means that the higher the score, the severe the pain is. Change values were calculated as Baseline value minus value at Week 6. | Baseline and Week 6 |
| Daegu |
| South Korea |
| Kwangjoo | South Korea |
| Kyunggi-Do | South Korea |
| Seoul | South Korea |
| Uijeongbu-si | South Korea |
| Inappropriate participant |
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| Participants' evasion for hospital visit |
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| Participants' non-cooperation |
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| Adverse event and insufficient effect |
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| Participants' non-cooperation |
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| Other |
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| Topiramate Slow |
Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. |
| BG002 | Topiramate Slow and Propranolol Booster | Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6. |
| BG003 | Total | Total of all reporting groups |
| Number |
| Participants |
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| Sex: Female, Male | Gender was measured for ITT population which was defined as participants who took topiramate at least once and had migraine improvement data at the Week 6. | Count of Participants | Participants |
|
| OG001 | Topiramate Slow | Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. |
| OG002 | Topiramate Slow and Propranolol Booster | Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6. |
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| Secondary | Change From Baseline in Migraine Frequency at Week 6 | The migraine frequency at Week 6 was evaluated through a headache diary completed by a participant and the reduction rate of migraine frequency compared to the Baseline period was measured. Change values were calculated as Baseline value minus value at Week 6. | The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point. | Posted | Mean | Standard Deviation | Migraine episodes/Week | Baseline and Week 6 |
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| Secondary | Change From Baseline in Migraine Disability Assessment (MIDAS) Score at Week 6 | MIDAS scoring ranges from 0 to 63. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability). Change values were calculated as Baseline value minus value at Week 6. | The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 6 |
|
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|
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| Secondary | Change From Baseline in Visual Analogue Scale (VAS) Score at Week 6 | VAS was used to measure the intensity of migraine. The assessment scale ranges from 0 to 10. One end of the line drawn on the questionnaire is marked with 0 point indicating "no headache" and the other end with 10 points indicating "unimaginably strong headache." It means that the higher the score, the severe the pain is. Change values were calculated as Baseline value minus value at Week 6. | The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Week 6 |
|
|
|
|
| 0 |
| 81 |
| 62 |
| 81 |
| EG001 | Topiramate Slow | Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. | 0 | 83 | 62 | 83 |
| EG002 | Topiramate Slow and Propranolol Booster | Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6. | 0 | 79 | 54 | 79 |
| Dizziness | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA Version 10.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Psychomotor retardation | Psychiatric disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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PI cannot provide any trial related information to external parties' without mutual agreement with the Sponsor. This is valid even after the contract is cancelled.
| D009422 | Nervous System Diseases |
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