Study to Improve the Treatment of Epilepsy (SITE)

Study Overview
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Brief Summary
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The purpose of this study is to assess whether changing antiepileptic medication can reduce side effects and improve the quality of life in patients with epileptic seizures that are well controlled with antiepileptic drugs.

Detailed Description
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Background. The aim of the treatment with antiepileptic drugs (AEDs) is to achieve seizure freedom without causing side effects. Assessment of side effects is difficult. They may start insidiously, the patient may not associate certain complaints with the use of AEDs, or the treating physician does not take enough time to discuss this topic during the limited time of a visit in the outpatient department. We know from clinical trials that side effects occur in a substantial group of patients. We do not know whether we deal with this possible complication in an adequate way in clinical practice. Study objective. To study whether adjustment of medication will reduce the occurrence of side effects and improve quality of life. Study design. A randomised clinical trial comparing adjustment of treatment in case of relevant side effects to continuing treatment unchanged. Relevant side effects are defined as at least one moderate or serious problem scored on a questionnaire to assess complaints in people with epilepsy. Patients who do not report relevant side effects will be followed for 13 months (arm A) in which two visits are scheduled, after 7 and 13 months respectively. The patients who do report relevant side effects will be randomised to either discussion of the questionnaire results and adjustment of treatment if appropriate (arm B) or to ignore the results of the questionnaire and continue treatment unchanged (arm C). Investigations will be repeated in both groups after 7 and 13 months after the initial visit.

Official Title
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Study to Improve the Treatment of Epilepsy (SITE). A Randomized Study Comparing Adjustment of Treatment to Reduce Side Effects of Antiepileptic Drugs With Continuing Treatment Unchanged

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: All registered antiepileptic drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older Treatment: antiepileptic drugs for epilepsy No change in medication during last 6 months No obvious clinical reason to change medication immediately Exclusion Criteria: Concurrent disease or disorder that might interfere with the conduct of the study Inability to comply to the protocol Impaired intellectual functioning, leading to inability to comply to the protocol and complete the necessary questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: All registered antiepileptic drugs|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complaints (questionnaire) at 7 and 13 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (Qolie-10) at 7 and 13 months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy, antiepileptic drugs, side effects, quality of life