Epilepsy Nervous System Diseases Episodic and paroxysmal disorders
Conditions
Interventions
Phenobarbitone versus phenytoin, in which the assessor is blinded to the treatment allocation and patient is given information on the side effects of both anti-epileptic drugs together, but is not awa
Sponsors
University of Oxford (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Adults (greater than 17 years) with active epilepsy, i.e. two or more seizures within the last year and the following seizure types: 1. Tonic-clonic 2. Partial becoming generalised 3. Partial motor
Exclusion criteria
Exclusion criteria: 1. Subjects who have received antiepileptic drugs in the past 2. Subjects with absence, myoclonic or atonic seizures 3. Subjects with progressive neurological disease 4. Subjects with severe learning difficulties 5. Less than 18 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of side effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to next seizure after starting treatment using an epilepsy history questionnaire 2. Seizure frequency: frequency of seizures will be monitored using seizure calendars, which the subjects will be educated on keeping 3. Compliance with drugs: drug compliance will be assessed by direct measurement of drug levels in blood at the initial contact and at 12 months; and using saliva samples at the end of 1, 3, 6 and 12 months. This will be reinforced by tablet counting and information elicited from patients/caregivers 4. Quality of life measure as developed for this proposal 5. Cognitive effects: subjects will have a culturally appropriate test of cognitive function performed at 6 months and 1 and 3 years afterwards | — |
Countries
Kenya
Outcome results
None listed