Comparison of a Drug and Placebo in the Prevention of Migraine Headaches

Exclusion Criteria

• •Migraine diagnosis:
• •Veterans with headache must have migraine categorized using the International Headache Society (I.H.S.) criteria as illustrated below for the two main types with and without aura.
• •Criteria for migraine without aura (I.H.S. 1.1)
• •\> 5 attacks
• •headache lasting 4-72 hours when untreated or not successfully treated.
• •headache with two of the following characteristics
• •* unilateral,
• •* pulsating,
• •* moderate to severe intensity,
• •* aggravation by exertion.
• •one of the following occurs with headache
• •* nausea and/or vomiting
• •* photophobia and phonophobia
• •Criteria for migraine with aura (I.H.S. 1.2)
• •at least 2 attacks
• •at least three of the following characteristics:
• •* One or more fully reversible aura symptoms indicating focal cerebral cortical - and/or brain stem dysfunction.
• •One or more aura symptoms of the following types:
• •Homonymous visual disturbance
• •Unilateral parenthesis and/or numbness
• •Unilateral weakness
• •Aphasia or unclassifiable speech difficulty
• •* At least one aura symptom develops gradually over more than 4 minutes or, 2 or more symptoms occur in succession.
• •* No aura symptom lasts more than 60 minutes. If more than one aura symptom is present, accepted duration is proportionally increased.
• •* Headache follows aura with a free interval of less than 60 minutes. (It may also begin before or simultaneously with the aura). Headache, nausea and/or photophobia usually follow neurological aura symptoms directly or after a free interval of less than an hour. The headache usually lasts 4-72 hours, but may be completely absent (1.2.5, acephalgic migraine).
• •Veterans with migraine plus other systemic disorder will be excluded if migraine onset was temporally related to onset of the systemic disorder.
• •Blood pressure elevations (must be \< borderline values 135/85 for 4 weeks before enrollment into the study). Current treatment for hypertension with beta-blockers, calcium channel blockers, or ace inhibitors not allowed.
• •Use of other prophylactic migraine drugs (requires a washout phase) and cannot have failed more than two other prophylactic drugs for migraine.
• •Excessive use of acute pain medicines, including narcotics (\>10 days month). Those using non-narcotics could be tapered off over 4-8 weeks.
• •Receiving disability or seeking disability for headache or chronic pain.
• •Significant neck pain or cervicogenic contributors to chronic headache.
• •Significant depression, anxiety, post-traumatic stress disorder, or other disabling psychiatric condition.
• •Known allergies or serious side effects with ESX or succinimides in the past.
• •Known liver or significant renal disease.
• •Women veterans of child-bearing age who do not have adequate birth control.
• •Chronic bone marrow suppression.
• •Using psychogenic or other sedating maintenance drugs.
• •History of porphyria.
• •History of cluster headache. 15.History of other CNS disease.
• •Age younger than 18 years and greater than 65.
• •Women veterans who are breastfeeding.
• •Veterans with familial hemiplegic migraine (FHM).
• •Ongoing exclusions during the study:
• •The addition of other migraine prophylactic headache medicines is not allowed. 2. New drugs cannot be added that aggravate headache (nitrates, dipyridamole, niacin).