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
Eli Lilly and Company
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects who are male or female between the ages of 18 and 65, inclusive
Subjects who have a history of migraine with or without aura as defined by IHS criteria, for at least one year prior to screening
Subjects who experience between 3 and 10 migraine attacks per month, for the three months preceding screening
Subjects who have no more than 15 headache days per month
Subjects who have been on a stable dose (no clinically significant changes) of all daily medications, for any indication, from 28 days prior to screening through the duration of the trial.
Women who are using, or agree to use for the duration of the study, a medically acceptable form of contraception (as determined by the investigator), if female of childbearing potential.
Subjects who are able to understand and comply with all study requirements
Subjects who provide written informed consent prior to any study procedures being performed.
You may not be if
Women who are pregnant or lactating
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 with QTC interval greater than 450ms will be excluded)
Subjects currently taking, or have taken within the thirty days prior to screening, any neuroleptics \> 1 day per week (such as Geodon, Zyprexa, Compazine, Phenergan, Seroquel and other drugs in the same class)
Subjects currently taking or have taken within 4-weeks prior to screening any medication for the prevention of migraine
Subjects who have failed more than two adequate trials of migraine prophylaxis, as determined by investigator
Subjects who experience significant orthostatic hypotension, as determined by the investigator
Subjects who, in the investigators opinion, have a history or have evidence of a medical 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 who, in the investigators opinion, have a history or have evidence of a 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 who have participated in an investigational drug trial in the 30 days prior to the screening visit
