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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017961-52 | EudraCT Number |
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This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients with partial onset seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGG492 low dose | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| BGG492 high dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational new drug, company code: BGG492 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period. | 28 days | |
| Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Clinics at St. Joseph's Hospital and MC | Phoenix | Arizona | 85013 | United States | ||
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| Label | URL |
|---|---|
| Results for CBGG492A2207 on the Novartis clinical trials website | View source |
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| Drug |
|
| Investigational new drug, company code: BGG492 | Drug |
|
| 28 days |
| Safety and tolerability of BGG492 compared to placebo. | 12 weeks |
| Pharmacokinetic profile of BGG492 | 10 weeks |
| Center for Neurosciences |
| Tucson |
| Arizona |
| 85718 |
| United States |
| Clinical Trials, Inc. | Little Rock | Arkansas | 72205 | United States |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | United States |
| AMO Corporation | Tallahassee | Florida | 32308 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Investigative Site - Private Practice | Ocean Springs | Mississippi | 39564 | United States |
| St.John's Research Institute, Inc | Springfield | Missouri | 65804 | United States |
| Renown Institute for Neurosciences | Reno | Nevada | 89521 | United States |
| NJ to Capital Health in Hamilton | Somerset | New Jersey | 08873 | United States |
| Princeton and Rutgers Neurology | Somerset | New Jersey | 08873 | United States |
| NYU Comprehensive Epilepsy Center | New York | New York | 10016 | United States |
| Thomas Jefferson University, Dept. of Psychiatry & Neurology | Philadelphia | Pennsylvania | 19107 | United States |
| Neurological Clinic of Texas | Dallas | Texas | 75230 | United States |
| Novartis Investigative Site | Sofia | 1113 | Bulgaria |
| Novartis Investigative Site | Bernau | 16321 | Germany |
| Novartis Investigative Site | Bielefeld | 33617 | Germany |
| Novartis Investigative Site | Bonn | 53127 | Germany |
| Novartis Investigative Site | Kehl-Kork | 77694 | Germany |
| Novartis Investigative Site | Marburg | Germany |
| Novartis Investigative SIte | Regensburg | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Ulm | Germany |
| Novartis Investigative Site | Budapest | 1096 | Hungary |
| Novartis Investigative Site | Kecskemét | 6000 | Hungary |
| Novartis Investigative Site | Szombathely | 9700 | Hungary |
| Novartis Investigative Site | Bologna | 40123 | Italy |
| Novartis Investigative Site | Catanzaro | 88100 | Italy |
| Novartis Investigative Site | Florence | 50143 | Italy |
| Novartis Investigative Site | Milan | 20142 | Italy |
| Novartis Investigative Site | Milan | 40123 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Venezia | 30122 | Italy |
| Novartis Investigative Site | Gdansk | 80-303 | Poland |
| Novartis Investigative Site | Krakow | 31-209 | Poland |
| Novartis Investigative Site | Warsaw | 02-957 | Poland |
| Novartis Investigative Site | Banská Bystrica | 975 17 | Slovakia |
| Novartis Investigative Site | Bratislava | Slovakia |
| Novartis Investigative Site | Košice | 041 90 | Slovakia |
| Novartis Investigative Site | Seoul | 110-744 | South Korea |
| Novartis Investigative Site | Seoul | 120-752 | South Korea |
| Novartis Investigative Site | Seoul | 135-710 | South Korea |
| Novartis Investigative Site | Seoul | 738-736 | South Korea |
| Novartis Investigative Site | Aarau | 5001 | Switzerland |
| Novartis Investigative Site | Bern | 3010 | Switzerland |
| Novartis Investigative Site | Zurich | 8008 | Switzerland |
| Novartis Investigative Site | Changhua | Taiwan |
| Novartis Investigative Site | Kaohsiung City | Taiwan |
| Novartis Investigative Site | Lin-ko | 33305 | Taiwan |
| Novartis Investigative Site | Taipei | 112 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015507 | Drugs, Investigational |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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