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
|First Submitted Date ICMJE||August 17, 2005|
|First Posted Date ICMJE||August 22, 2005|
|Last Update Posted Date||October 21, 2005|
|Start Date ICMJE||October 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Complaints (questionnaire) at 7 and 13 months|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00133081 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Quality of Life (Qolie-10) at 7 and 13 months|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study to Improve the Treatment of Epilepsy (SITE)|
|Official Title ICMJE||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|
|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.|
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 ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Drug: All registered antiepileptic drugs|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Completion Date||August 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Netherlands|
|Removed Location Countries|
|NCT Number ICMJE||NCT00133081|
|Other Study ID Numbers ICMJE||SITE|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||UMC Utrecht|
|PRS Account||UMC Utrecht|
|Verification Date||March 2004|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP