Epilepsy Clinical Trial
— VASSCAOfficial title:
Clinical Validation Study of the Simplified Seizure Classification Algorithm
NCT number | NCT03796520 |
Other study ID # | EpiPick-1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2, 2019 |
Est. completion date | December 31, 2020 |
Verified date | February 2021 |
Source | Aarhus University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
An algorithm has been developed for simplified classification of epileptic seizures, in order to optimize choice of antiepileptic drugs. The objective of this study was to clinically validate the algorithm.
Status | Completed |
Enrollment | 240 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 10 Years to 120 Years |
Eligibility | Inclusion Criteria: - patients referred to the participating centers on suspicion of epilepsy Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Danish Epilepsy Centre | Dianalund | |
Iran, Islamic Republic of | Shiraz University of Medical Sciences | Shiraz | |
Italy | University of Pavia | Pavia | |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sándor Beniczky | Danish Epilepsy Centre, Shiraz University of Medical Sciences, Thomas Jefferson University, University of Pavia |
United States, Denmark, Iran, Islamic Republic of, Italy,
Beniczky S, Rubboli G, Aurlien H, Hirsch LJ, Trinka E, Schomer DL; SCORE consortium. The new ILAE seizure classification: 63 seizure types? Epilepsia. 2017 Jul;58(7):1298-1300. doi: 10.1111/epi.13799. — View Citation
Brodie MJ, Covanis A, Gil-Nagel A, Lerche H, Perucca E, Sills GJ, White HS. Antiepileptic drug therapy: does mechanism of action matter? Epilepsy Behav. 2011 Aug;21(4):331-41. doi: 10.1016/j.yebeh.2011.05.025. Epub 2011 Jul 16. Review. — View Citation
Brodie MJ, Elder AT, Kwan P. Epilepsy in later life. Lancet Neurol. 2009 Nov;8(11):1019-30. doi: 10.1016/S1474-4422(09)70240-6. Epub 2009 Oct 1. Review. — View Citation
Brodie MJ. Practical Use of Newer Antiepileptic Drugs as Adjunctive Therapy in Focal Epilepsy. CNS Drugs. 2015 Nov;29(11):893-904. doi: 10.1007/s40263-015-0285-4. Review. — View Citation
Fisher RS, Cross JH, French JA, Higurashi N, Hirsch E, Jansen FE, Lagae L, Moshé SL, Peltola J, Roulet Perez E, Scheffer IE, Zuberi SM. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):522-530. doi: 10.1111/epi.13670. Epub 2017 Mar 8. — View Citation
Stephen LJ, Brodie MJ. Selection of antiepileptic drugs in adults. Neurol Clin. 2009 Nov;27(4):967-992. doi: 10.1016/j.ncl.2009.06.007. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AC1 | Agreement coefficient between index test (EpiPick) and the reference standard (expert classification) | Through study completion, an average of 8 months. |
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