Objective
To assess the comparative efficacy and tolerability of add-on therapy versus alternative monotherapy in epileptic patients with partial seizures refractory to initial treatment or sequential monotherapies.
To determine the optimal therapeutic strategy in epileptic patients with epilepsy refractory to initial treatment or sequential monotherapies, 440 patients with partial non-idiopathic epilepsy who had failed to achieve freedom from seizures despite treatment with a single drug will be randomized to two groups. One group will be crossed-over to an alternative drug having a different mechanism of action (for example, carbamazepine or vigabatrin in patients who had failed on valproic acid monotherapy and valproic acid or vigabatrin in patients who had failed on carbamazepine monotherapy) while in the other group the alternative drug will be added on. In both groups drug dosage will be individualized based on clinical response and serum drug level determinations. Seizure frequency and the occurrence of adverse events will be assessed over a 1-year follow-up period to assess potential differences between the two groups. The primary outcome parameter will be represented by retention time on the allocated treatment policy. Other outcome parameters will include: dissatisfaction time with the allocated treatment policy, time to first seizure after achieving target dosage, proportion of patients achieving at least a 50% reduction in seizure frequency during the last 3 months of follow-up, proportion of patients becoming seizure free and achieving 6-month remission, seizure number at different study periods compared with seizure number at baseline, number of treatment failures, proportion of patients with adverse events.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
You need to log in or register to use this function
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Data not available
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
27100 Pavia
Italy
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.