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Study to Improve the Treatment of Epilepsy (SITE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2004 by UMC Utrecht.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00133081
First Posted: August 22, 2005
Last Update Posted: December 9, 2005
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.
Collaborator:
GlaxoSmithKline
Information provided by:
UMC Utrecht
  Purpose
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.

Condition Intervention Phase
Epilepsy Drug: All registered antiepileptic drugs Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Complaints (questionnaire) at 7 and 13 months

Secondary Outcome Measures:
  • Quality of Life (Qolie-10) at 7 and 13 months

Estimated Enrollment: 255
Study Start Date: October 2002
Estimated Study Completion Date: August 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Netherlands
AZM
Maastricht, Limburg, Netherlands, 6202 AZ
Catharina Hospital
Eindhoven, Noord Brabant, Netherlands, 5623 EJ
Hospital Gooi-Noord
Blaricum, Noord Holland, Netherlands, 1250 CA
Oosterschelde Hospital
Goes, Zeeland, Netherlands, 4460 BB
MCRZ
Rotterdam, Zuid Holland, Netherlands, 3007 AC
MC Haaglanden
The Hague, Zuid Holland, Netherlands, 2512 VA
Sponsors and Collaborators
UMC Utrecht
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
  More Information

ClinicalTrials.gov Identifier: NCT00133081     History of Changes
Other Study ID Numbers: SITE
First Submitted: August 17, 2005
First Posted: August 22, 2005
Last Update Posted: December 9, 2005
Last Verified: March 2004

Keywords provided by UMC Utrecht:
epilepsy
antiepileptic drugs
side effects
quality of life

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants