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Table 2 Important inclusion criteria which may affect outcome

From: International veterinary epilepsy task force consensus proposal: outcome of therapeutic interventions in canine and feline epilepsy

Criteria for the diagnosis of epilepsy

How exclusion of other episodic events (paroxysmal dyskinesias, tremors, episodic collapse etc.) is achieved, which are likely not to respond to interventions with AEDs

Criteria to restrict the study population under investigation to specific patient groups, breed-specific epilepsies, specific etiologies

E. g. if restriction to patients with idiopathic epilepsy, implies to define specific measures and examinations undertaken to exclude other causes of epilepsy that are known to influence outcome in a significant manner. These criteria should follow the requirements for the diagnosis of idiopathic epilepsy as defined in a separate consensus statement.

 

Description of the specific pharmacoresistance pattern of the study population under investigation e. g. resistance to phenobarbital, potassium bromide, imepitoin, levetiracetam etc. Definition of pharmacoresistance should follow previous consensus in this paper, which may include definition of minimum serum concentrations, requirements for measurement of trough levels and definition of steady state periods as deemed necessary based on mechanism of action for the specific drug for which pharmacoresistance is defined.

Criteria to restrict the study population to a specific disease stage

Criteria to restrict the study population under investigation either to

• trials of AEDs in patients with new onset epilepsy, or

• trials of AEDs in patients with chronic refractory epilepsy

Criteria for pre-drug assessment in trials of AEDs in patients with chronic epilepsy

Definition of baseline data (e.g. written seizure diary, prospective, retrospective) and duration of baseline period for assessment of median pre-treatment seizure frequency, cluster seizure frequency or assessment of the longest seizure-free interval in the year preceding study inclusion

Criteria to restrict the study population to patients without severe systemic disease which will likely affect outcome

E. g. exclude severe preexisting hepatic, renal, endocrine disease