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

Sponsor:	Thomas Jefferson University
Collaborator:	Valeant Pharmaceuticals International, Inc.
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00203268

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.

Condition	Intervention
Migraine Cutaneous Allodynia	Drug: dihydroergotamine mesylate

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Dihydroergotamine Dihydroergotamine mesylate

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

describe the difference, if any, in subjects who treat a migraine attack early (within 2 hours) with DHE-45 and those who treat later (within 4 hours) and relate this to the presence or absence of established cutaneous allodynia.

Estimated Enrollment:	10
Study Start Date:	December 2003
Estimated Study Completion Date:	March 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203268

Locations

United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Valeant Pharmaceuticals International, Inc.

Investigators

Principal Investigator:

Stephen D Silberstein, MD

Thomas Jefferson University, Jefferson Headache Center

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00203268 History of Changes
Other Study ID Numbers:	SDS/DHE/01
Study First Received:	September 13, 2005
Last Updated:	January 22, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:

migraine
cutaneous allodynia

Additional relevant MeSH terms:

Migraine Disorders
Hyperalgesia
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms
Dihydroergotamine
Dopamine Agonists

Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012