Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache
Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache
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.
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.
Inclusion Criteria:

 -  Subject is 18-65 years of age

 -  Diagnosis of migraine with or without aura

 -  1 year history of migraine with 1-6 migraine attacks per month in the the three months
 prior to screening

 -  Medication for migraine prevention with a stable dose for at least 1 month prior to
 screening

 -  Has successfully treated a migraine attack with a triptan medication

 Exclusion Criteria:

 -  Confirmed or suspected ischemic heart disease

 -  History of congenital heart disease

 -  History of cerebrovascular disease, including stroke

 -  History of ischemic abdominal disease

 -  Uncontrolled hypertension

 -  History of epilepsy

 -  History of basilar or hemiplegic migraine

 -  Impaired hepatic or renal function

 -  Greater than 15 headache days per month

 -  Subjects on an MAOI

 -  Subjects taking and ergotamine, or ergot containing preventive medication

 -  Subject is pregnant, trying to become pregnant or breast feeing

 -  Evidence of alcohol or substance abuse in the last year

 -  History of caffeine withdrawal headache

 -  Consumes more than 275 mg of caffeine on daily basis from dietary and medication
 sources

 -  Taking propanolol