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#5\"","Dnipro","49027","Ukraine","UA",{"type":36,"coordinates":1189},[1190,1191],35.04066,48.46664,{"lat":1191,"lon":1190},{"facility":1194,"status":26,"city":1195,"state":26,"zip":1196,"country":1186,"countryCode":1187,"cosmosGeoPoint":1197,"geoPoint":1199,"contacts":26},"Komunalnyi zaklad \"Dnipropetrovska oblasna dytiacha klinichna likarnia\"","Dnipropetrovsk","49100",{"type":36,"coordinates":1198},[1190,1191],{"lat":1191,"lon":1190},{"facility":1201,"status":26,"city":1202,"state":26,"zip":1203,"country":1186,"countryCode":1187,"cosmosGeoPoint":1204,"geoPoint":1208,"contacts":26},"Ivano-Frankivska oblasna dytiacha klinichna likarnia","Ivano-Frankivsk","76018",{"type":36,"coordinates":1205},[1206,1207],24.71248,48.92312,{"lat":1207,"lon":1206},{"facility":1210,"status":26,"city":1211,"state":26,"zip":1212,"country":1186,"countryCode":1187,"cosmosGeoPoint":1213,"geoPoint":1217,"contacts":26},"Derzhavna ustanova \"Instytut nevrolohii, psykhiatrii ta narkolohii","Kharkiv","61068",{"type":36,"coordinates":1214},[1215,1216],36.25475,49.98177,{"lat":1216,"lon":1215},{"facility":1219,"status":26,"city":1211,"state":26,"zip":1212,"country":1186,"countryCode":1187,"cosmosGeoPoint":1220,"geoPoint":1222,"contacts":26},"Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady \"Oblasna klinichna psykhiatrychna li",{"type":36,"coordinates":1221},[1215,1216],{"lat":1216,"lon":1215},{"facility":1224,"status":26,"city":1225,"state":26,"zip":1226,"country":1186,"countryCode":1187,"cosmosGeoPoint":1227,"geoPoint":1231,"contacts":26},"Derzhavnyi zaklad \"Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam","Kyiv","04209",{"type":36,"coordinates":1228},[1229,1230],30.5238,50.45466,{"lat":1230,"lon":1229},{"facility":1233,"status":26,"city":1234,"state":26,"zip":1235,"country":1186,"countryCode":1187,"cosmosGeoPoint":1236,"geoPoint":1240,"contacts":26},"Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lv","Lviv","79010",{"type":36,"coordinates":1237},[1238,1239],24.02324,49.83826,{"lat":1239,"lon":1238},{"facility":1242,"status":26,"city":1243,"state":26,"zip":1244,"country":1186,"countryCode":1187,"cosmosGeoPoint":1245,"geoPoint":1249,"contacts":26},"Komunalna ustanova \"Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia\"","Odesa","65006",{"type":36,"coordinates":1246},[1247,1248],30.74383,46.48572,{"lat":1248,"lon":1247},{"facility":1251,"status":26,"city":1243,"state":26,"zip":1244,"country":1186,"countryCode":1187,"cosmosGeoPoint":1252,"geoPoint":1254,"contacts":26},"Komunalne nekomertsiine pidpryiemstvo \"Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdoroviaa\"",{"type":36,"coordinates":1253},[1247,1248],{"lat":1248,"lon":1247},{"facility":1256,"status":26,"city":1243,"state":26,"zip":1257,"country":1186,"countryCode":1187,"cosmosGeoPoint":1258,"geoPoint":1260,"contacts":26},"KU \"Odeska oblasna dytiacha klinichna likarnia\"","65031",{"type":36,"coordinates":1259},[1247,1248],{"lat":1248,"lon":1247},{"facility":1262,"status":26,"city":1263,"state":26,"zip":1264,"country":1186,"countryCode":1187,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Komunalna ustanova \"Odeska oblasna psykhiatrychna likarnia No2\"","S. Oleksandrivka, Kominternivskyi R-n, Odeska Obl.","67513",{"facility":1266,"status":26,"city":1267,"state":26,"zip":1268,"country":1186,"countryCode":1187,"cosmosGeoPoint":1269,"geoPoint":1273,"contacts":26},"Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii No2","Uzhhorod","88018",{"type":36,"coordinates":1270},[1271,1272],22.2947,48.6242,{"lat":1272,"lon":1271},{"facility":1275,"status":26,"city":1276,"state":26,"zip":1277,"country":1186,"countryCode":1187,"cosmosGeoPoint":1278,"geoPoint":1282,"contacts":26},"Komunalna ustanova \"Miska klinichna likarnia #2\", nevrolohichne viddilennia","Zaporizhzhia","69068",{"type":36,"coordinates":1279},[1280,1281],35.74246,47.15214,{"lat":1281,"lon":1280},{"facility":1284,"status":26,"city":1285,"state":1286,"zip":1287,"country":1288,"countryCode":1289,"cosmosGeoPoint":1290,"geoPoint":1294,"contacts":26},"The Barberry National Centre for Mental Health","Birmingham","WEST Midlands","B15 2FG","United Kingdom","UK",{"type":36,"coordinates":1291},[1292,1293],-1.89983,52.48142,{"lat":1293,"lon":1292},{"facility":1296,"status":26,"city":1297,"state":26,"zip":1298,"country":1288,"countryCode":1289,"cosmosGeoPoint":1299,"geoPoint":1303,"contacts":26},"Salford Royal NHS Foundation Trust","Salford","M6 8HD",{"type":36,"coordinates":1300},[1301,1302],-2.29042,53.48771,{"lat":1302,"lon":1301},{"type":1305,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100168224","phase-3-a-12-month-study-to-evaluate-the-safety-and-tolerability-of-pregabalin-as-add-on-therapy-in-pediatric-subjects-1-month-to-16-years-of-age-with-partial-onset-seizures-and-pediatric-and-adult-subjects-5-to-65-years-of-age-with-primary-generalized-tonic-clonic-seizures-100168224",true,"NCT01463306","A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures","A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS 1 MONTH TO 16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES AND PEDIATRIC AND ADULT SUBJECTS 5 TO 65 YEARS OF AGE WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES","Inclusion Criteria:\n\n* Subjects and\u002For parent(s)\u002Flegally acceptable representative must be considered willing and able to sign consent, and complete daily dosing and seizure diaries and complete all scheduled visits.\n* Male and female epilepsy subjects, 1 month to 65 years of age inclusive on the date of the Screening Visit.\n* Diagnosis of epilepsy with seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, or primary generalized tonic-clonic seizures according to the International League Against Epilepsy (ILAE 2010) Diagnosis Criteria.\n* Partial onset seizure subjects must have had an average of at least 3 seizures per 28 day period in the 3 months prior to screening.\n* Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).\n\nExclusion Criteria:\n\n* Lennox-Gastaut syndrome, Infantile Spasms, Absence seizures, BECT (Benign Epilepsy with Centrotemporal Spikes), and Dravet syndrome,\n* A current diagnosis of febrile seizures or any febrile seizure within 1 year of screening.\n* Status epilepticus within 1 year prior to visit 1.\n* Seizures related to drugs, alcohol, or acute medical illness.\n* Progressive structural CNS lesion or a progressive encephalopathy.",false,"ALL","1 Month","66 Years",{"count":1318,"type":1319},605,"ACTUAL","INTERVENTIONAL",[1322],"PHASE3","Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.",[1325,1326],"Epilepsy, Partial Seizures","Epilepsy, Primary Generalized Tonic-Clonic Seizures",[1328,1329,1330,1331,1332,1333,1334,1335],"safety","partial onset seizures","primary generalized tonic-clonic seizures","pregabalin","pediatric","adult","open-label","long term","COMPLETED","2021-01-15",{"date":1339,"type":1319},"2021-01-20",{"date":1341,"type":1319},"2012-02-21",{"date":1343,"type":1319},"2019-08-22",{"name":1345,"class":6},"Pfizer's Upjohn has merged with Mylan to form Viatris Inc.",151]