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Study was never initiated under new location/provider group. Contract to continue was never signed between TEVA and Kennedy Headache Center
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| Name | Class |
|---|---|
| Teva Pharmaceuticals USA | INDUSTRY |
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The primary objective of the study is to evaluate the effectiveness and safety of cyclobenzaprine hydrochloride extended release (Amrix 15mg/day) for the prophylaxis of chronic migraine compared to a placebo medication. A second objective, is to find out whether there is an improvement in quality of sleep and self-reported depression in patients taking Amrix 15mg daily. The hypothesis is that the number of migraine days per month of patients treated with Amrix 15mg daily will be significantly lower than those patients treated with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cyclobenzaprine hydrochloride | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclobenzaprine hydrochloride | Drug | 15mg daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean total number of migraine/migrainous headache days per month | The principle outcome variable will be the mean total number of migraine/migrainous headache days which will be calculated for the month prior to enrollment in the study (pretreatment) and then calculated for the third month after study treatment (posttest) after taking 15mg of Amrix or the placebo. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean total number of headache days/month | 4 months | |
| mean peak daily and mean average daily pain intensity ratings/month | 4 months | |
| mean total number of abortive treatment days/month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loretta Mueller, DO | Kennedy Medical Group dba The Headache Center at Kennedy Health Alliance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Headache Center at Kennedy Health Alliance | Cherry Hill | New Jersey | 08002 | United States |
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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 |
|---|---|
| C004704 | cyclobenzaprine |
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| placebo | Drug | placebo |
|
| 4 months |
| D009422 | Nervous System Diseases |