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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | INDUSTRY |
| H. Lundbeck A/S |
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This will be a cross-sectional study enrolling 200 outpatients/inpatients with treatment resistant partial epilepsy for at least two years, receiving 1-3 AEDS.
The study will consist of one or two visits, each lasting 1-2 hours. All subjects will complete Visit 1. Twenty five percent of the subjects will return for Visit 2. The study will assess the prevalence of depression and suicidal thoughts and the feasibility of using the proposed psychiatric rating scales in future epilepsy clinical trials. This study will also provide an estimate of the proportion of patients with epilepsy (PWE) who may be ineligible for future trials.
In light of the recent issues regarding antiepileptic drugs and suicidality, The Epilepsy Study Consortium is proposing a pilot study. Several scales to assess suicidality and screen for depression and anxiety disorders will be administered to a group of epilepsy patients with characteristics similar to patients who are usually enrolled in epilepsy clinical trials. The study will assess the prevalence of depression, suicidal thoughts, and behavior and the feasibility of using the proposed psychiatric rating scales in future epilepsy clinical trials. This study will also provide an estimate of the proportion of patients with epilepsy who may be ineligible for future trials because they have had active suicidal thoughts in the last 6 months, suicidal behavior in the last 2 years or a current major depressive episode.
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Inclusion criteria:
Exclusion criteria:
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Patients with partial epilepsy for at least two years, who are treatment resistant, experience at least 1 seizure/month, and are receiving 1-3 AEDs/month will be selected.
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline French, M.D. | NYU Langone Medical Center | Principal Investigator |
| Andres Kanner, M.D. | Rush University Medical Center | Principal Investigator |
| Dale Hesdorffer, PhD, MPH | Columbia University | Principal Investigator |
| Kelly Posner, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The International Center for Epilepsy (ICE) at the University of Miami | Miami | Florida | 33136 | United States | ||
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| Label | URL |
|---|---|
| The Epilepsy Study Consortium | View source |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| INDUSTRY |
| Pfizer | INDUSTRY |
| Supernus Pharmaceuticals, Inc. | INDUSTRY |
| UCB Pharma | INDUSTRY |
| Upsher-Smith Laboratories | INDUSTRY |
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| Rush Epilepsy Center |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Johns Hopkins Hospital, Adult Epilepsy Center | Baltimore | Maryland | 21287 | United States |
| NYU Comprehensive Epilepsy Center | New York | New York | 10016 | United States |
| The Penn Epilepsy Center | Philadelphia | Pennsylvania | 19104 | United States |
| Jefferson Comprehensive Epilepsy Center | Philadelphia | Pennsylvania | 19107 | United States |