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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with dihydroergotamine mesylate (DHE-45) | Experimental | Subjects who treated a moderate to severe migraine 2 and 4 hours after the onset of throbbing headache pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dihydroergotamine mesylate | Drug | 1.0 mg. intramuscularly |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen D Silberstein, MD | Thomas Jefferson University, Jefferson Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Headache Center | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Subjects who treated a moderate to severe migraine at 1 hour and at 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. intramuscular (IM). Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Treatment |
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| Late Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Subjects who treated a moderate to severe migraine 2 hours and 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 2 hours post treatment and 4 hours post treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Treatment | Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| burning at injection site | Skin and subcutaneous tissue disorders | burning | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen D. Silberstein, MD | Thomas Jefferson University | 215-955-2243 | Stephen.Silberstein@Jefferson.edu |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004087 | Dihydroergotamine |
| ID | Term |
|---|---|
| D004879 | Ergotamines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Late Treatment | Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe |
|
|
|
| 0 |
| 13 |
| 3 |
| 9 |
| EG001 | Late Treatment | Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe | 0 | 13 | 3 | 9 |
| muscle spasm, quadricep | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | Nausea | Non-systematic Assessment |
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| Medicinal taste aversion | Nervous system disorders | taste aversion | Non-systematic Assessment |
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| D009422 | Nervous System Diseases |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |