Meeting Ownersˋ Expectations in Epilepsy Studies: Individual Study Endpoints

Presentation Description / Summary: There is a need for prospective studies in canine and feline epilepsy, which provide firm evidence for the efficacy of treatment strategies. Data in epilepsy treatment studies usually rely on precise documentation of epileptic seizures by the dog or cat owners in seizure diaries. Conventional study protocols are conducted in a parallel group or cross-over design and compare the treatment under investigation to a placebo or standard of care. These require treatment over pre-defined periods independent of individual seizure frequency. High drop-out rates and lack of owner compliance can impair data quality. Owner compliance is especially a concern if there is no improvement with the treatment under investigation, if there are side effects and also if long treatment periods are required to adjust for natural fluctuations of the disease, as is the case in epilepsy. Novel study designs which use individual outcome parameters (e.g., n-th seizure after intervention) could overcome some of these issues and will be discussed based on current evidence in epilepsy trials in veterinary and human medicine. A secondary aim is to raise awareness for the impact of seizure documentation and seizure classification as focal, focal to bilateral tonic-clonic or generalized epileptic seizures, exclusion of paroxysmal dyskinesia, and to raise awareness for underreporting of non-convulsive epileptic seizures.