A Phase 4 interventional study of Topiramate Standard and Topiramate Slow in Migraine, sponsored by Janssen Korea, Ltd., Korea. Completed at 6 sites in South Korea. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-08-22.
Sponsored by Janssen Korea, Ltd., Korea (part of Johnson & Johnson) · Phase 4, Interventional, and Treatment
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.
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
This study's enrollment of 250 is above the median of 80 across 1,197 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Janssen Korea, Ltd., Korea is the lead sponsor of 79 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: Topiramate Standard
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.
Drug: Topiramate Slow
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.
Drug: Topiramate Slow · Drug: Propranolol booster
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.
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.
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).
Time frame: Maintenance period (Weeks 7 to 10)
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.
Time frame: Baseline and Week 6
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.
Time frame: 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.
Time frame: Baseline and Week 6
| Milestone | Topiramate Standard | Topiramate Slow | Topiramate Slow and Propranolol Booster |
|---|---|---|---|
| Started | 81 | 84 | 80 |
| Treated | 81 | 83 | 79 |
| Completed | 54 | 61 | 45 |
| Not completed | 27 | 23 | 35 |
| Withdrew: Adverse event | 9 | 5 | 18 |
| Withdrew: Lack of efficacy | 2 | 1 | 0 |
| Withdrew: Inappropriate participant | 5 | 4 | 5 |
| Withdrew: Participants' evasion for hospital visit | 0 | 3 | 2 |
| Withdrew: Participants' non-cooperation | 8 | 6 | 6 |
| Withdrew: Adverse event and insufficient effect | 0 | 1 | 0 |
| Withdrew: Participants' non-cooperation | 1 | 0 | 0 |
| Withdrew: Other | 2 | 3 | 4 |
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).
| Percentage decrease in migraine episodes | Topiramate Standard | Topiramate Slow | Topiramate Slow and Propranolol Booster |
|---|---|---|---|
| Percentage Decrease in Migraine Episodes | 48 ± 69 | 57 ± 48 | 46 ± 69 |
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.
| Migraine episodes/Week | Topiramate Standard | Topiramate Slow | Topiramate Slow and Propranolol Booster |
|---|---|---|---|
| Baseline | 1.48 ± 0.76 | 1.58 ± 0.80 | 1.59 ± 0.87 |
| Change at Week 6 (n=51, 57, 43) | 0.89 ± 1.04 | 0.89 ± 0.88 | 0.74 ± 1.31 |
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.
| Units on a scale | Topiramate Standard | Topiramate Slow | Topiramate Slow and Propranolol Booster |
|---|---|---|---|
| Baseline | 1.32 ± 1.26 | 1.29 ± 1.14 | 1.42 ± 1.77 |
| Change at Week 6 (n=54, 61, 44) | 0.99 ± 1.18 | 0.99 ± 1.08 | 0.95 ± 2.00 |
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.
| Units on a Scale | Topiramate Standard | Topiramate Slow | Topiramate Slow and Propranolol Booster |
|---|---|---|---|
| Baseline | 5.83 ± 1.55 | 5.68 ± 1.68 | 5.51 ± 1.78 |
| Change at Week 6 (n= 53, 59, 42) | 1.83 ± 2.54 | 2.45 ± 2.84 | 2.31 ± 2.32 |
Collected over Baseline up to Week 10. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Topiramate Standard | — | 0/81 (0%) | 62/81 (76.5%) |
| Topiramate Slow | — | 0/83 (0%) | 62/83 (74.7%) |
| Topiramate Slow and Propranolol Booster | — | 0/79 (0%) | 54/79 (68.4%) |
| Event | Topiramate Standard | Topiramate Slow | Topiramate Slow and Propranolol Booster |
|---|---|---|---|
| ParesthesiaNervous system disorders | 42/81 | 48/83 | 36/79 |
| DizzinessNervous system disorders | 5/81 | 9/83 | 14/79 |
| Weight decreasedInvestigations | 14/81 | 7/83 | 9/79 |
| Gastrointestinal disorderGastrointestinal disorders | 6/81 | 5/83 | 11/79 |
| AnorexiaMetabolism and nutrition disorders | 5/81 | 3/83 | 8/79 |
| Psychomotor retardationPsychiatric disorders | 1/81 | 3/83 | 8/79 |
| SomnolenceNervous system disorders | 3/81 | 3/83 | 7/79 |
| HeadacheNervous system disorders | 7/81 | 5/83 | 3/79 |
| ParaesthesiaNervous system disorders | 6/81 | 5/83 | 3/79 |
| NauseaGastrointestinal disorders | 1/81 | 2/83 | 5/79 |
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.
| Age, Customized(Participants) | Topiramate Standard | Topiramate Slow | Topiramate Slow and Propranolol Booster | Total |
|---|---|---|---|---|
| Age 20 and over but younger than age 30 | 16 | 23 | 22 | 61 |
| Age 30 and over but younger than age 40 | 24 | 27 | 30 | 81 |
| Age 40 and over but younger than age 50 | 22 | 19 | 16 | 57 |
| Age 50 and over but younger than age 60 | 11 | 11 | 7 | 29 |
| Age 60 and over | 7 | 2 | 2 | 11 |
| Sex: Female, Male(Participants) | Topiramate Standard | Topiramate Slow | Topiramate Slow and Propranolol Booster | Total |
|---|---|---|---|---|
| Female | 72 | 76 | 63 | 211 |
| Male | 9 | 7 | 15 | 31 |
The record gives a start of Jul 2006, a primary completion of Jul 2008 and a completion of Jul 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2013, 5 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.