Clareo Health | A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Thomas Jefferson University
With
Bausch Health Americas, Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
