{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T02:49:48Z","timestamp":1789008588646,"version":"build-2803163510"},"reference-count":9,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2013,7,22]],"date-time":"2013-07-22T00:00:00Z","timestamp":1374451200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"NIH","award":["R01 NS45656"],"award-info":[{"award-number":["R01 NS45656"]}]},{"name":"GCRC of Children's National Medical Center"},{"name":"UCB Pharma, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2013,9]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Posttraumatic seizures develop in up to 20% of children following severe traumatic brain injury (<jats:styled-content style=\"fixed-case\">TBI<\/jats:styled-content>). Children ages 6\u201317\u00a0years with one or more risk factors for the development of posttraumatic epilepsy, including presence of intracranial hemorrhage, depressed skull fracture, penetrating injury, or occurrence of posttraumatic seizure were recruited into this phase II study. Treatment subjects received levetiracetam 55\u00a0mg\/kg\/day, b.i.d., for 30\u00a0days, starting within 8\u00a0h postinjury. The recruitment goal was 20 treated patients. Twenty patients who presented within 8\u201324\u00a0h post\u2010<jats:styled-content style=\"fixed-case\">TBI<\/jats:styled-content> and otherwise met eligibility criteria were recruited for observation. Follow\u2010up was for 2\u00a0years. Forty\u2010five patients screened within 8\u00a0h of head injury met eligibility criteria and 20 were recruited into the treatment arm. The most common risk factor present for pediatric inclusion following <jats:styled-content style=\"fixed-case\">TBI<\/jats:styled-content> was an immediate seizure. Medication compliance was 95%. No patients died; 19 of 20 treatment patients were retained and one observation patient was lost to follow\u2010up. The most common severe adverse events in treatment subjects were headache, fatigue, drowsiness, and irritability. There was no higher incidence of infection, mood changes, or behavior problems among treatment subjects compared to observation subjects. Only 1 (2.5%) of 40 subjects developed posttraumatic epilepsy (defined as seizures &gt;7\u00a0days after trauma). This study demonstrates the feasibility of a pediatric posttraumatic epilepsy prevention study in an at\u2010risk traumatic brain injury population. Levetiracetam was safe and well tolerated in this population. This study sets the stage for implementation of a prospective study to prevent posttraumatic epilepsy in an at\u2010risk population.<\/jats:p>","DOI":"10.1111\/epi.12326","type":"journal-article","created":{"date-parts":[[2013,7,22]],"date-time":"2013-07-22T18:44:49Z","timestamp":1374518689000},"source":"Crossref","is-referenced-by-count":70,"title":["Results of phase <scp>II<\/scp> levetiracetam trial following acute head injury in children at risk for posttraumatic epilepsy"],"prefix":"10.1111","volume":"54","author":[{"given":"Phillip L.","family":"Pearl","sequence":"first","affiliation":[{"name":"Department of Neurology Children's National Medical Center Washington District of Columbia U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"McCarter","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Children's National Medical Center Washington District of Columbia U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colleen L.","family":"McGavin","sequence":"additional","affiliation":[{"name":"Department of Neurology Children's National Medical Center Washington District of Columbia U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuezhou","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Neurology Children's National Medical Center Washington District of Columbia U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabian","family":"Sandoval","sequence":"additional","affiliation":[{"name":"Department of Neurology Children's National Medical Center Washington District of Columbia U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stacey","family":"Trzcinski","sequence":"additional","affiliation":[{"name":"Department of Neurology Children's National Medical Center Washington District of Columbia U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shireen M.","family":"Atabaki","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine Children's National Medical Center Washington District of Columbia U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tammy","family":"Tsuchida","sequence":"additional","affiliation":[{"name":"Department of Neurology Children's National Medical Center Washington District of Columbia U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"van den Anker","sequence":"additional","affiliation":[{"name":"Department of Pharmacology Children's National Medical Center Washington District of Columbia U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianping","family":"He","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Children's National Medical Center Washington District of Columbia U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pavel","family":"Klein","sequence":"additional","affiliation":[{"name":"Mid\u2010Atlantic Epilepsy and Sleep Center Bethesda Maryland U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,7,22]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2008-0607"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)60214-2"},{"key":"e_1_2_7_4_1","first-page":"1","article-title":"Results of phase II safety and feasibility study of treatment with levetiracetam for prevention of posttraumatic epilepsy","volume":"9","author":"Klein P","year":"2012","journal-title":"Arch 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