Study to Improve the Treatment of Epilepsy (SITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00133081
Recruitment Status : Unknown
Verified March 2004 by UMC Utrecht.
Recruitment status was:  Active, not recruiting
First Posted : August 22, 2005
Last Update Posted : October 21, 2005
Information provided by:
UMC Utrecht

August 17, 2005
August 22, 2005
October 21, 2005
October 2002
Not Provided
Complaints (questionnaire) at 7 and 13 months
Same as current
Complete list of historical versions of study NCT00133081 on Archive Site
Quality of Life (Qolie-10) at 7 and 13 months
Same as current
Not Provided
Not Provided
Study to Improve the Treatment of Epilepsy (SITE)
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
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: All registered antiepileptic drugs
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
August 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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UMC Utrecht
Study Director: Cees A van Donselaar, MD PhD UMC Utrecht
Principal Investigator: Sabine G Uijl, MSc UMC Utrecht
Principal Investigator: Albert P Aldenkamp, PhD AZM Maastricht
Principal Investigator: Cuno SP Uiterwaal, PhD UMC Utrecht
UMC Utrecht
March 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP