An Efficacy and Tolerability Study of Topiramate in Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Topiramate Standard; Topiramate Slow; Propranolol booster
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Topiramate; Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Migraine; Topiramate; Propranolol