A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 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, 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

Treatment and study plan

dihydroergotamine mesylate

Drug

1.0 mg. intramuscularly

Other names: DHE-45

Primary outcomes

Number of Subjects Reporting Headache Relief at the 2 Hour Post Treatment Assessment. Relief Was Measured as a 2-point Change on a 4-point Scale (0=None, 1=Mild, 2=Moderate, 3=Severe)in Both the Early Treatment and Late Treatment Groups.

Time frame: 2 hours post treatment and 4 hours post treatment

Data was collected at 2 hours post treatment to assess pain level. This assessment was done when subjects treated a migraine early (defined as treatment at 2 hours after onset of throbbing pain)and then late (defined as treatment at 4 hours after onset of throbbing pain). The proportion of subjects reporting headache relief at the 2 hour post treatment assessment was determined for each group and then compared.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

Bausch Health Americas, Inc.

Registry information

Official study 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

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Sep 20, 2005
Registry last updated: Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed