CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
dihydroergotamine mesylatedrug
Likely dose
Dihydroergotamine mesylate 1.0 mg intramuscularlyAI-extracted
Key inclusion· 6
  • Age 18-65 years
  • Diagnosed with episodic migraine (with or without aura) per International Headache Criteria for ≥1 year
  • Experience 3-10 migraine attacks per month with no more than 15 days of headache per month
  • Report migraine pain as pulsating/throbbing
Key exclusion· 11
  • Pregnant or lactating women
  • History of basilar or hemiplegic migraine
  • Previous hypersensitivity to ergot alkaloids
  • History of non-response to DHE-45

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00203268
NCT00203268N/ACompleted

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

Thomas Jefferson University·interventional·Posted Sep 20, 2005·Updated Jun 9, 2014

In Brief

A clinical study evaluating dihydroergotamine mesylate for Migraine. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartDec 1, 2003
Primary CompletionMar 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.8 years ago

Interventions

dihydroergotamine mesylatedrug

1.0 mg. intramuscularly