At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Adequate Therapy of Topiramate in Migraine
In Brief
A Phase 4 clinical trial evaluating Topiramate Standard, Topiramate Slow, and 1 other intervention for Migraine. Completed, enrolled 250 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.