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A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity
This study has been completed.
Sponsor:
Thomas Jefferson University
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203268
First received: September 13, 2005
Last updated: May 8, 2014
Last verified: May 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
| Migraine | Drug: dihydroergotamine mesylate |
| Study Type: | Interventional |
| Study Design: | 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:
Further study details as provided by Thomas Jefferson University:
Primary Outcome Measures:
- 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.
| Enrollment: | 13 |
| Study Start Date: | December 2003 |
| Study Completion Date: | March 2005 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment with dihydroergotamine mesylate (DHE-45)
Subjects who treated a moderate to severe migraine 2 and 4 hours after the onset of throbbing headache pain
|
Drug: dihydroergotamine mesylate
1.0 mg. intramuscularly
Other Name: DHE-45
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203268
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
| Responsible Party: | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00203268 History of Changes |
| Other Study ID Numbers: |
SDS/DHE/01 |
| Study First Received: | September 13, 2005 |
| Results First Received: | October 25, 2010 |
| Last Updated: | May 8, 2014 |
Keywords provided by Thomas Jefferson University:
|
migraine cutaneous allodynia |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Dihydroergotamine Vasoconstrictor Agents Dopamine Agonists |
Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on July 18, 2017