Study to Improve the Treatment of Epilepsy (SITE)

October 20, 2005 updated by: UMC Utrecht

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

255

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ
        • azM
    • Noord Brabant
      • Eindhoven, Noord Brabant, Netherlands, 5623 EJ
        • Catharina Hospital
    • Noord Holland
      • Blaricum, Noord Holland, Netherlands, 1250 CA
        • Hospital Gooi-Noord
    • Zeeland
      • Goes, Zeeland, Netherlands, 4460 BB
        • Oosterschelde Hospital
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3007 AC
        • MCRZ
      • The Hague, Zuid Holland, Netherlands, 2512 VA
        • MC Haaglanden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Complaints (questionnaire) at 7 and 13 months

Secondary Outcome Measures

Outcome Measure
Quality of Life (Qolie-10) at 7 and 13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

GlaxoSmithKline

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion

August 1, 2006

Study Registration Dates

First Submitted

August 17, 2005

First Submitted That Met QC Criteria

August 17, 2005

First Posted (ESTIMATE)

August 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2005

Last Update Submitted That Met QC Criteria

October 20, 2005

Last Verified

March 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SITE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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