To evelauate whether the presence of selected polymorphisms has an effect on the response to lamotrigine.
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence of selected polymorphisms in the three patient groups.
Secondary outcome
Number of antiepileptic drugs used; epilepsy subtype; seizure type.
Background summary
Patients with the similar type of epilepsy and seizure type may respond
differently to specific antiepilepltic drugs. The background for these
differences is largely unknown. Possibly genetic differences, and especially
polymorphisms, contribute to this variation in drug response. Polymorphisms are
genetic variations that occur in more than 1% of the population.
Study objective
To evelauate whether the presence of selected polymorphisms has an effect on
the response to lamotrigine.
Study design
After recruitment into the study, 20 ml of venous blood is collected from each
patient and DNA is isolated from these blood samples. Recruited patients are
divided into three groups: patients that became seizure free on lamotrigine;
patients that did not achieve seizure freedom on lamotrigine, but did become
seizure free on another antiepileptic drug or combination of drugs; treatment
resistant patients.
Polymorphisms will be selected that may be of significance to the efficacy of
lamotrigine. The presence of these polymorrphims will be assessed in the DNA of
patients.
Study burden and risks
A 20 ml blood sample is collected once.
Postbus 563
8000 AN Zwolle
Nederland
Postbus 563
8000 AN Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
General inclusion criteria
1. Adult patients with cryptogenic or symptomatic localization-related epilepsy, manifesting in generalized tonic-clonic, complex partial and/or simple partial seizures.
2. Patients that are able to understand the written information about the study and are able to give informed consent.
Exclusion criteria
Exclusion criteria:
1. Patients failing valproate due to other reasons than persisting seizures despite a maximum tolerated dose (i.e. failure due to adverse effects on a starting dose of valproate, failure due to non-compliance etc).
2. Patients with generalized epilepsy and/or generalized absence-seizures and /or myoclonic seizures.
3. Acute or progressive neurological disease.
4. History of psychiatric disease or substance addiction.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12085.058.06 |