Clinical trial NCT01060111: An Efficacy and Tolerability Study of Topiramate in Participants With Migraine
Official title: Adequate Therapy of Topiramate in Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
Topiramate
Propranolol
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Particpants who have signed the consent form
* Participants who have 3 to 14 episodes of migraine a month
* Participants whose duration of migraine is at least 6 months
* Participants who can read and understand the migraine disability assessment (MIDAS) questionnaire
* Female Participants who are using an appropriate contraception method or have negative pregnancy test results

Exclusion Criteria:

* Participants whose headache attacks at Baseline or during the study period are assumed to be caused by a drug withdrawal syndrome
* Participants whose migraine has appeared first at over 50 years of age
* Participants who have taken anticonvulsants (valproic acid, gabapentin), beta adrenergic blockers (propranolol) and calcium antagonists (sibelium, verapamil, diltiazem) or topiramate or propranolol within the last 8 weeks
* Participants with progressive neurological (pertaining to the nervous system) disorder
* Participants with severe renal (pertaining to the kidneys) disorder, hepatic (pertaining to the liver) failure or diabetes (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects) or with the history of renal calculus

Primary outcomes:
measure: Percentage Decrease in Migraine Episodes
timeFrame: Maintenance period (Weeks 7 to 10)
Secondary outcomes:
measure: Change From Baseline in Migraine Frequency at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Migraine Disability Assessment (MIDAS) Score at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Visual Analogue Scale (VAS) Score at Week 6
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Kwangjoo
country: Korea, Republic of
city: Kyunggi-Do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Uijeongbu
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: