Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.
Condition: Migraine; Headache; Classic Migraine; Common Migraine
MeSH terms: Migraine Disorders; Migraine with Aura; Migraine without Aura; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Topiramate is effective in preventing the
      development of chronic daily headache among patients with episodic migraine headaches.
    

Detailed description: 
      Chronic daily headache encompasses a frequent headache state in which the increased burden of
      pain further compromises quality of life and adversely impacts patients, their families, and
      health care providers. Approximately 5% of patients with migraine, or an estimated 1.4
      million Americans, manifest a chronic daily headache form of disease. The consequences
      include resistance to treatment, worsening quality of life, increased use and over use of
      medication, and development of ischemic and other neuropathological brain lesions. This is a
      randomized, double-blind, placebo-controlled multicenter study that will enroll patients
      18-65 years old with an established history of migraine headaches who, in the 28 days prior
      to the study should have a migraine frequency of at least 10 but less than 15 migraine
      headache days per month, and less than 15 total headache days (migraine plus non migraine
      headaches) per month. The study duration will be approximately 26 weeks. The study is divided
      into 4 phases as follows: A Screening/Washout Phase that may last between 2-6 weeks,
      depending on whether you need to stop taking a medication that is not allowed in the study; A
      Baseline Phase lasting 4 weeks, at which time information will be collected on the migraine
      and non-migraine headaches you experience during this period; A double-blind Titration Phase
      lasting 4-6 weeks where all patients will be randomized to treatment with either Topiramate
      or placebo. If you are randomized to Topiramate, your dose will be gradually increased up to
      a dose of either 75 or 100 mg a day; A Maintenance Period lasting 20 weeks at which time you
      will continue on the dose you were taking at the completion of the Titration period; and a
      Taper/Exit phase, lasting 2 weeks, where you will gradually reduce the dose of study
      medication you were taking during the study. The study hypothesis is that the study drug will
      be more effective than placebo in preventing patients from transforming from episodic
      migraines to chronic daily headaches. Each patient will be asked to record their headache
      pain information and medication use on paper headache diaries. Patients will receive either
      Topiramate or placebo. The number of tablets of topiramate or placebo, will be gradually
      increased to either a minimum of 3 tablets/day or a maximum of 4 tablets/day. For those on
      Topiramate, 3 tablets would represent 75 mg and 4 tablets would represent 100 mg/day.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Migraine; Headache; Migraine Headache