None listed
Conditions
Brief summary
Levetiracetam is being compared with lamotrigine and sodium valproate in patients with new-onset epilepsy who have unclassified seizures. Four other closely related trials are being conducted, with the entry criteria for each trial determined by the seizure type that the patient experiences. Sustained seizure freedom (at least 12 months seizure free) is the primary endpoint.
Interventions
EpiNet-First Trial 4: patients with generalised seizures for whom sodium valproate is suitable will be randomised (1:1:1) to receive levetiracetam or lamotrigine or sodium valpoate.
Levetiracetam. Oral medication. Duration of treatment administration = 2 years. Dose to be determined by investigator according to usual clinical practice. The range of doses will vary from 250 mg to 4000 mg (oral tablets) daily in two divided doses and will be determined as considered clinically appropriate by the
EpiNet-First Trial 4: patients with generalised seizures for whom sodium valproate is suitable will be randomised (1:1:1) to receive levetiracetam or lamotrigine or sodium valpoate. Levetiracetam. Oral medication. Duration of treatment administration = 2 years. Dose to be determined by investigator according to usual clinical practice. The range of doses will vary from 250 mg to 4000 mg (oral tablets) daily in two divided doses and will be determined as considered clinically appropriate by the investigator. Adherence will be assessed by the investigators checking regularly with patients whether they are taking the drug as prescribed. Serum drug levels are not required as part of the study, but will be monitored as determined by the investigator and considered appropriate for good clinical care. Lamotrigine. Oral medication. Duration of treatment administration = 2 years. Dose to be determined by investigator according to usual clinical practice. The range of doses will vary from 25 mg to 400 mg (oral tablets) daily in two divided doses and will be determined as considered clinically appropriate by the investigator.
Sponsors
EpiNet Study Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for EpiNet Trial 4 is as follows: 1-Aged 5 years or older on date of consent 2-The investigator is confident that the patient has epilepsy 3-Two or more spontaneous generalized seizures that require antiepileptic drug treatment (provided all seizures have not been absence seizures); 4-Antiepileptic drug monotherapy considered the most appropriate option 5-Willing to provide consent. For patients younger than the age of consent (usually 16 years), patient's parent/legal representative willing to give consent,
Exclusion criteria
1-Provoked seizures (e.g. alcohol, recreational drugs) 2-Acute symptomatic seizures (e.g. acute brain haemorrhage or acute brain injury) 3-Absence seizures as only seizure type 4-Psychogenic non-epileptogenic seizures 5-Has ever been treated with an antiepileptic for more than one week 6-Known progressive neurological disease (e.g. brain tumour)
Outcome results
None listed