Status:
COMPLETED
A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00203268
Start Date
December 1 2003
End Date
March 1 2005
Last Update
June 9 2014
Active Locations (1)
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1
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107