A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity
A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity
This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It
 will be used to treat two migraine attacks in subjects who have a history of skin sensitivity
 associated with their headaches.This skin sensitivity is called cutaneous allodynia
 (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a
 non-noxious stimulus is applied to normal skin. It has been noted in several studies that in
 subjects with migraine, seventy nine percent of the subjects experienced allodynia on the
 facial skin on the same side as the headache. It has also been shown that that once allodynia
 develops, other migraine medicines that would normally be very effective for migraine pain,
 become much less effective or ineffective. This study will compare the differences,if any, in
 attacks treated early with this study drug and treated later with the same study drug. It is
 hoped that that this trial will provide information on the use of DHE-45 in subjects who have
 cutaneous allodynia. Understanding more about allodynia may help us understand how the pain
 system works in migraine.
Inclusion Criteria:

 -  Male and female subjects between the ages of 18 and 65, inclusive

 -  Subjects diagnosed with episodic migraine, with or without aura according to
 International Headache Criteria (IHS) (Appendix B) for at least one-year prior to
 screening

 -  Subjects who experience between 3-10 migraine attacks per month (during the previous 6
 months) with no more than 15 days of headache per month.

 -  Subjects who report their migraine pain quality as pulsating/ throbbing.

 -  Subject is using or agrees to use for the duration of participation a medically
 acceptable form of contraception (as determined by investigator), if female of
 child-bearing potential

 -  Subjects who are able to come for 2-hour in-clinic treatment of two separate migraine
 attacks

 -  Subjects who are able to understand and comply with all study procedures.

 -  Subject provides written informed consent prior to any screening procedures being
 conducted

 Exclusion Criteria:

 -  Pregnant and/or lactating women

 -  Subjects who, in the investigators opinion, have a history or have evidence of a
 medical or psychiatric condition that would expose them to an increased risk of a
 significant adverse event or would interfere with the assessments of efficacy and
 tolerability during this trial

 -  Subjects with an abnormal ECG that, in the investigators opinion, would expose them to
 increased risk of adverse events or interfere with study drug and/or analysis of
 efficacy/tolerability

 -  Subjects currently using, or expecting to use during the trial, Cytochrome P450 3A4
 (CYP3A4 enzymes) inhibitors (such as protease inhibitors and macrolide antibiotics)

 -  Subjects with severely impaired hepatic or renal function, as determined by the
 investigator

 -  Subjects who have participated in an investigational drug trial in the 30 days prior
 to the screening visit

 -  Subjects who currently have or have a history of basilar or hemiplegic migraine

 -  Subjects who have previously shown hypersensitivity to ergot alkaloids

 -  Subjects who have a history of non-response to DHE-45, as determined by investigator

 -  Subjects with uncontrolled hypertension

 -  Subjects who currently have or who have a history of ischemia and/or vasospastic
 coronary artery disease

 -  Subjects who, in the investigators opinion, have significant risk factors of coronary
 artery disease