Philadelphia, Pennsylvania 19107

  • Cutaneous Allodynia

Purpose:

This is a research study examining a migraine medicine called DHE-45.It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).It has been noted in several studies that in subjects with migraine, seventy nine percent of the subjects experienced allodynia on the facial skin on the same side as the headache. It has also been shown that that once allodynia develops, other migraine medicines that would normally be very effective for migraine pain, become much less effective or ineffective. This study will compare the differences,if any, in attacks treated early with this study drug and treated later with the same study drug. It is hoped that that this trial will provide information on the use of DHE-45 in subjects who have cutaneous allodynia. Understanding more about allodynia may help us understand how the pain system works in migraine.


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 criteria (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, CYP 3A4 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


NCT ID:

NCT00203268


Primary Contact:

Principal Investigator
Stephen D Silberstein, MD
Thomas Jefferson University, Jefferson Headache Center


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19107
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.