A Dose-Finding Study of Topiramate (JNS019) in Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Topiramate; Placebo
Intervention description: In the titration period, topiramate 25-mg tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks so that the total daily dose given is 50 mg or 100mg. The dose given in the final titration week will be continued for further 18 weeks (fixed dose period).; In the titration period, matching placebo tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks. The dose given in the final titration week will be continued for further 18 weeks (fixed dose period).
Intervention MeSH terms: Topiramate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 387.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Topiramate; Migraine

Summary:

      The purpose of this study is to determine a recommended dose of topiramate in participants
      with migraine (type of severe headache that occurs periodically and is often associated with
      nausea, vomiting, and constipation or diarrhea), to verify the superiority (statistically
      more effective) of the drug to placebo (an inactive substance that is compared with a drug to
      test whether the drug has a real effect in a clinical trial), and to assess if a same
      therapeutic effect can be observed between this study and overseas Caucasian clinical
      studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who meet the Second Edition of the International Classification of
             Headache Disorders (ICHD-II), 1.1 Migraine without aura or 1.2 Migraine with aura over
             at least 6 months before the time of informed consent

          -  Participants who had an average of no more than 8 migraine attacks per month during 3
             months before informed consent and an average of no more than 14 headache (migraine
             and non-migraine) days

          -  Participants whose number of migraine attacks during the baseline determination period
             (28 days) is 3 to 12 according to the 24-hour rule and number of headache days
             (migraine and non-migraine) is no more than 14

          -  Participants who took no migraine preventive medications over 2 weeks before informed
             consent, or who can take at least 2-week washout period before baseline determination
             period if they are taking migraine preventive medications

          -  Female participants must be postmenopausal, surgically sterile, abstinent, or can take
             adequate contraceptive measures after informed consent and continue it to the
             completion of investigational treatment

        Exclusion Criteria:

          -  Participants who cannot distinguish between migraine and non-migraine headache

          -  Participants with headache other than those described in the ICHD-II, 1.1 Migraine
             without aura, 1.2 Migraine with aura, 2. Tension headache or 11.5 Sinus headache

          -  If the participant has received drug therapies for prevention of migraine, the
             discontinued preventive therapies due to insufficient efficacy should be at least
             three types

          -  Participants who excessively took medications for migraine attacks such as analgesics
             (drug used to control pain) as medications to be taken as needed within 3 months
             before informed consent

          -  Participants who have taken topiramate (test drug in this study) in the past