Overview

This trial is active, not recruiting.

Condition epilepsy
Treatment all registered antiepileptic drugs
Phase phase 4
Sponsor UMC Utrecht
Collaborator GlaxoSmithKline
Start date October 2002
End date August 2006
Trial size 255 participants
Trial identifier NCT00133081, SITE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Complaints (questionnaire) at 7 and 13 months
time frame:

Secondary Outcomes

Measure
Quality of Life (Qolie-10) at 7 and 13 months
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Sabine G Uijl, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2005.
Information provided to ClinicalTrials.gov by UMC Utrecht.