[P3.280] Use of Investigator Training to Improve Seizure Classification in PREVAIL: A Phase 3, Global Study Evaluating USL255, Once-Daily Extended-Release Topiramate, in Adults With Partial-Onset Seizures
Bree DiVentura,1Jacqueline French,1,2Bob Anders,3Dawn Laine3
1Herndon, VA, USA, 2New York City, NY, USA, 3Maple Grove, MN, USA
OBJECTIVE: Assess seizure misclassification rates following implementation of a seizure training program for investigators and coordinators participating in a phase 3 trial evaluating the efficacy and safety of USL255 as adjunctive therapy in subjects with partial-onset seizures (PREVAIL; NCT01142193).
BACKGROUND: As seizure misclassification can negatively impact trial outcomes, The Epilepsy Study Consortium has created a training program for study investigators and coordinators to consistently identify the type of seizure and provide independent verification of seizure classification.
DESIGN/METHODS: A seizure identification video, providing detailed descriptions of seizure types and advice for patient interviews, was moderated by a Consortium member at investigator meetings. After the video, a quiz was administered, with answers discussed in real time. PREVAIL was the first trial to implement this quiz with required retraining for scores <70%. Seizure Identification Forms (SIFs) were submitted for each subject, which included subject/caregiver-based seizure descriptions and investigator-based classification(s) of seizure(s). Prior to randomization, the Consortium reviewed and approved all SIFs; misclassifications were communicated to the study team to allow for investigator retraining. Subject diaries were assessed by centralized CRO reviewers to ensure seizure type and counts met protocol-specified criteria.
RESULTS: The Epilepsy Consortium reviewed and reconciled 308 SIFs; only 1 subject was deemed unsuitable for PREVAIL. Eleven subjects (3.6%) had 12 misclassified seizures; a rate lower than previously reported (14% , 10% ) for other trials. Complex partial seizures (CPS) were the most commonly misclassified, representing 8 (66.7%) of the 12. The 4 remaining misclassifications included 2 cases each of secondarily generalized tonic-clonic seizures and simple partial seizures w/motor signs.
CONCLUSIONS: In conjunction with The Epilepsy Study Consortium, the USL255 PREVAIL trial implemented the use of a novel video-based seizure identification training program, which may have contributed to the improved accuracy of seizure classification by the trial investigators versus historical comparisons.
Study Supported by: Upsher-Smith Laboratories, Inc.
Category - Epilepsy and Clinical Neurophysiology (EEG): Clinical Epilepsy
Tuesday, April 29, 2014 3:00 PM
P3: Poster Session III: Epilepsy and Clinical Neurophysiology: AED (3:00 PM-6:30 PM)