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It has been determined that continuing with enrollments in this study is no longer justified due to the lack of significant impact on the expected outcomes.
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The purpose of this study is to evaluate the efficacy of clorazepate in addition to the usual medication for treating migraine attack in the emergency room
Each patient will receive the usual migraine treatment: IV ketoprofen 100 mg and, if he suffers nausea and/or vomiting, additional IV metoclopramide 10 mg.
Depending on randomization assignment, patient will receive additional placebo (standard treatment arm) or additional IV Clorazepate 20 mg (study arm). The central pharmacy will be responsible for preparing the medications, using a double-blind protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Placebo Comparator | placebo and standard care :
|
|
| Experimental arm | Experimental | clorazepate and standard care :
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clorazepate Dipotassium | Drug | Clorazepate Dipotassium : 20 mg intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief | Percentage of patients "pain-relief" 2 hours after administration of the treatment | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Lariboisière | Paris | Île-de-France Region | 75010 | France |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020326 | Migraine without Aura |
| D020325 | Migraine with Aura |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D003009 | Clorazepate Dipotassium |
| D007660 | Ketoprofen |
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | Placebo IV |
|
| Ketoprofen | Drug | Ketoprofen 100 mg IV |
|
| Metoclopramide | Drug | Metoclopramide 10 mg IV |
|
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001549 | Benzamides |
| D000577 | Amides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |