A Dose-Finding Study of Topiramate (JNS019) in Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This study is a multicenter (more than 1 site), placebo-controlled (compared to placebo),
      randomized (participants assigned study drug by chance), double-blind (neither the
      participant nor the physician know the assigned study drug), parallel-group comparison
      (comparison for each group at the same time) study. The study period consists of 4 phases:
      the observation phase, double-blind phase, exit period and follow-up period. After the
      double-blind phase, the participants will be transferred to the continuous treatment study.
      The observation phase which is started after informed consent consists of the washout period
      (non-treatment period with migraine preventive medication: at least 2 weeks) and baseline
      determination period (at least 4 weeks). The participants who complete the observation phase
      and meet the inclusion criteria will be randomly assigned to the topiramate 50 milligram (mg)
      group, topiramate 100-mg group or placebo group after registration. The double-blind phase
      consists of the titration period (dose-escalation, 4 weeks) and fixed-dose period (18 weeks).
      In the titration period, starting from 1 topiramate 25-mg tablet or 1 topiramate 25-mg
      placebo tablet once daily (1 tablet in the evening), the dose will be increased by 1 tablet
      every week up to twice daily (2 tablets in the morning, 2 tablets in the evening). After
      that, the twice-daily treatment (2 tablets in the morning, 2 tablets in the evening) will be
      continued for 7 days from Day 22 to Day 28. In the fixed-dose period, the topiramate 25-mg
      tablets or topiramate 25-mg placebo tablets at the same dose as that in the final treatment
      in titration period will be continued. The participants who are not transferred to the
      continuous treatment study after completion of the double-blind phase or after
      discontinuation during the double-blind phase will be transferred to the exit period (up to 1
      week).The participants who complete the exit period will be transferred to the follow-up
      period, and a follow-up of the participant's safety and headache symptoms such as the
      migraine period rate will be conducted for 4 weeks after the completion of investigational
      treatment. Meanwhile, the participants who complete the double-blind phase or those who
      discontinue the study at Week 4 or later in the fixed-dose period during the double-blind
      phase due to lack of efficacy and give consent to transfer to the continuous treatment study
      will be transferred to the transfer period (up to 3 weeks) under blind conditions.
    

Intervention name(s): Topiramate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Topiramate; Migraine