Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-04 @ 8:07 AM
Study NCT ID:
NCT00203268
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
An Open Label Pilot Trial to Collect and Evaluate Data on the Use of Dihydroergotamine Mesylate in the Treatment of Two Migraine Attacks Associated With Cutaneous Allodynia
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a non-noxious stimulus is applied to normal skin. 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: