patients with epileptic encephalopathies
Conditions
Interventions
Product Name: Phenytoin
Pharmaceutical Form: Suspension for use in drinking water
INN or Proposed INN: Phenytoin
Current Sponsor code: PR1
Other descriptive name: PHENYTOIN
Concentration unit: mg/ml m
Sponsors
University of Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - highly active epilepsy (one or more seizures per day) with onset at 3 months of age or before - pharmo-resistance (2 or more anticonvulsive medications tried before with no effect) - max. 2 stable anticonvulsive drugs at study start Are the trial subjects under 18? yes Number of subjects for this age range: 25 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - high-grade cardial rhythm disease - severe pathology of liver or renal function - severe change in blood counts or electrolytes - metabolic or lesional epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to identify a specfic effect of phenytoin and lacosamide on patients with epileptic encephalpathy with mutations in the following genes SCN2A, KCNQ2 or KCNT1 ;Secondary Objective: - to identify different effects in different mutations - to identify a reduction of epileptic EEG activity or suppression phases in the EEG under the specific medication;Primary end point(s): 50% reduction of seizure activity or more compared to baseline ;Timepoint(s) of evaluation of this end point: after 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 50% reduktion of seizure activity in different mutations - reduction of epileptic activity and suppression phases in EEG ;Timepoint(s) of evaluation of this end point: after 7 days | — |
Countries
Germany
Contacts
Public ContactKlinikumsvorstand
University of Tübingen
Outcome results
None listed