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

Condition(s) targeted: Migraine; Cutaneous Allodynia

Intervention: dihydroergotamine mesylate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Thomas Jefferson University

Official(s) and/or principal investigator(s):
Stephen D Silberstein, MD, Principal Investigator, Affiliation: Thomas Jefferson University, Jefferson Headache Center

This is a research study examinining 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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Primary outcome: 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Jefferson Headache Center, Philadelphia, Pennsylvania 19107, United States

Starting date: December 2003
Ending date: March 2005
Last updated: September 13, 2005