Clinical trial NCT00133081: Study to Improve the Treatment of Epilepsy (SITE)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Epilepsy
Keywords: epilepsy
antiepileptic drugs
side effects
quality of life
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-08-22
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complaints (questionnaire) at 7 and 13 months
Secondary outcomes:
measure: Quality of Life (Qolie-10) at 7 and 13 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: AZM
state: Limburg
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord Brabant
city: Blaricum
country: Netherlands
facility: Hospital Gooi-Noord
state: Noord Holland
city: Goes
country: Netherlands
facility: Oosterschelde Hospital
state: Zeeland
city: Rotterdam
country: Netherlands
facility: MCRZ
state: Zuid Holland
city: The Hague
country: Netherlands
facility: MC Haaglanden
state: Zuid Holland
Study officials:
affiliation: UMC Utrecht
name: Cees A van Donselaar, MD PhD
role: STUDY_DIRECTOR
affiliation: UMC Utrecht
name: Sabine G Uijl, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: AZM Maastricht
name: Albert P Aldenkamp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Cuno SP Uiterwaal, PhD
role: PRINCIPAL_INVESTIGATOR
References: