A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine
Migraine
About this trial
This is an interventional treatment trial for Migraine
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 IHS (International Headache Society) criteria (Appendix B) for at least one-year prior to screening Subjects who experience between 3-10 migraine attacks (inclusive) 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 experiences episodic migraine associated with cutaneous allodynia, as determined by the Cutaneous Allodynia screening tool and investigator. 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 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, CYP 3A4(CYP3A4 enzyme) 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 (dihydroergotamine) or Migranal®, 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
Arm 2
Experimental
Experimental
Migranal treatment first treatment phase
Migranal second treatment phase
All subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment phase), or late (first treatment phase) then early (second treatment phase).
All subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment phase), or late (first treatment phase) then early (second treatment phase).