A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity
Migraine
About this trial
This is an interventional treatment trial for Migraine focused on measuring migraine, cutaneous allodynia
Eligibility Criteria
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
Sites / Locations
- Jefferson Headache Center
Arms of the Study
Arm 1
Experimental
Treatment with dihydroergotamine mesylate (DHE-45)
Subjects who treated a moderate to severe migraine 2 and 4 hours after the onset of throbbing headache pain