An Efficacy and Tolerability Study of Topiramate in Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Topiramate Standard; Topiramate Slow; Propranolol booster
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; Topiramate; Propranolol

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.
    

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