Study to Improve the Treatment of Epilepsy (SITE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2004 by UMC Utrecht.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00133081
First received: August 17, 2005
Last updated: October 20, 2005
Last verified: March 2004
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00133081     History of Changes
Other Study ID Numbers: SITE
Study First Received: August 17, 2005
Last Updated: October 20, 2005
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014