An Open-label Study to Evaluate Topiramate Therapy in Migraine Patients, and Its Effects on Subject Responsiveness to Migraine Treatment With Triptans
Condition: Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether prophylactic use of topiramate (preventative
      use before a migraine attack) enhances the effectiveness of migraine treatment with triptans.
    

Detailed description: 
      The objective of this pilot study is to determine if patients with migraine are more
      responsive to triptans taken for symptomatic headache treatment while on topiramate
      prophylactic therapy as compared to a baseline period without prophylaxis. The trial is an
      open-label design, with migraine patients receiving topiramate prophylactically twice a day
      (maximum of 200 mg/day) for 16 weeks, following a 6-week Prospective Baseline Period.

      During the first week of the treatment phase, subjects will begin on a once-daily dose of 25
      mg of topiramate at night, and remain on that dose for two weeks. Thereafter, the daily dose
      will be increased by 25 mg, with twice-daily dosing. If in the investigator's judgement
      further dosage increases beyond 100 mg/day are indicated, the daily dose will be increased
      weekly by 25 mg to a daily dose of 150 mg. The daily dose may be increased to a maximum daily
      dose of 200 mg, if the subject is tolerating the higher doses.

      Subjects keep a headache diary in which the following information is recorded: time of onset
      of headache and indication of type of headache; time headache stops; any symptomatic
      treatment taken, time that tiptan medication is taken; headache intensity at the time the
      triptan is taken, 30 minutes, one hour, and two hours post dose; and the presence of nausea
      at the time the triptan is taken, 30 minutes, on hour, and 2 hours post dose. The primary
      measure of triptan responsiveness is the proportion of triptan treated migraine attacks that
      were pain-free at two hours after triptan treatment.

      Safety evaluations during the study include the collection of adverse events, laboratory
      assessments including hematology, chemistry and urinalysis, and vital signs (blood pressure
      and pulse). The hypothesis is that topiramate prophylaxis will increase the responsiveness of
      migraine attacks to triptan therapy as measured by the proportion of attacks that are
      pain-free two hours after triptan therapy. Subjects will begin week 1 of the Topiramate
      Treatment phase with 25 mg topiramate at night. Thereafter, the dose of topiramate will be
      increased by 25 mg every second week i.e. week 3 = 50 mg, week 5 =75 mg, week 7 = 100 mg. If,
      in the investigator's judgment, further dosage increases are indicated, the dose can be
      increased as follows: week 9 = 125 mg, week 10 = 150 mg, week 11 = 175 mg, week 12 = 200
      mgs.The dose may be increased weekly after week 10 if the patient is tolerating the higher.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Headache