Study to Improve the Treatment of Epilepsy (SITE)
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: All registered antiepileptic drugs||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||255 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2002|
|Estimated Study Completion Date :||August 2006|
- Complaints (questionnaire) at 7 and 13 months
- Quality of Life (Qolie-10) at 7 and 13 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133081
|Maastricht, Limburg, Netherlands, 6202 AZ|
|Eindhoven, Noord Brabant, Netherlands, 5623 EJ|
|Blaricum, Noord Holland, Netherlands, 1250 CA|
|Goes, Zeeland, Netherlands, 4460 BB|
|Rotterdam, Zuid Holland, Netherlands, 3007 AC|
|The Hague, Zuid Holland, Netherlands, 2512 VA|
|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|