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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Migraine

Intervention / Treatment
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* Drug: dihydroergotamine mesylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with dihydroergotamine mesylate (DHE-45)<br>Subjects who treated a moderate to severe migraine 2 and 4 hours after the onset of throbbing headache pain | Drug: dihydroergotamine mesylate<br>* 1.0 mg. intramuscularly<br>* Other names: DHE-45;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 hours post treatment and 4 hours post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, cutaneous allodynia