Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache
Condition: Migraine With Aura; Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with
      caffeine for treating acute attacks of migraine.

      Each subject will have 3 months to treat 3 acute migraine headache attacks. Each subject will
      be dispensed one box containing 3 packets of study medication labeled for Headache #1,
      Headache #2, or Headache #3. Each packet wil contain either Maxalt 10mg MLT or a Maxalt
      placebo (sugar pill), and a capsule containing either caffeine 75mg or a capsule containing
      placebo (sugar).

      One headache will be treated with a combination of Maxalt 10mg MLT and caffeine.

      Another headache will be treated with a combination of Maxalt 10mg MLT and a capsule
      containing placebo.

      A third headache will be treated with just placebo.

      Neither the subject, the study coordinator, or your study doctor will know in which order you
      will receive the three different treatments. This information is available in case of
      emergency.
    

Detailed description: 
      Oral Maxalt has an extensive record of providing relief of acute migraine headache with 2
      hours in the vast majority of patients, especially when undertaken as an early intervention
      strategy. Caffeine has been demonstrated to have analgesic effects in patients treating
      tension type headache and is found as part of a combination including aspirin and
      acetaminophen as a treatment for acute migraine headache.

      The mechanism by which Maxalt relieves migraine headache is believed to be through action on
      5HT1B/1D receptors both on blood vessels as well as centrally. Caffeine may have effects on
      relief of migraine through modifying norepinephrine related mechanisms which have been
      suggested through clinical research. Patients commonly report that they may obtain partial or
      complete relief of their migraines by consuming the modest amounts of caffeine found in a cup
      of coffee. this is estimated to be approximately 100mg per cup. The analgesic effects of
      caffeine appear to be most significant in the first 3 hours after ingestion. Recent work
      suggests that intervention in migraine when the pain is still mild and has not persisted for
      a prolonged duration may increase the likelihood of complete migraine response. Therefore,
      the combination of the two agents with activity in migraine that work early in the migraine
      process, have good tolerability at the proposed doses and working via different mechanism may
      increase the likelihood of patients achieving better response with their migraine treatment
      than that which is currently available.
    

Intervention name(s): Maxalt 10mg MLT plus Caffeine 75mg; Maxalt 10mg MLT plus Placebo; Placebo + Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One migraine attack will be treated; One migraine attack will be treated with Maxalt 10mg plus placebo; One migraine attack will be treated with double placebo
Intervention MeSH terms: Caffeine; Rizatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Migraine