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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 17, 2005

Last Updated Date

October 20, 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

Descriptive Information

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.

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: All registered antiepileptic drugs

Study Arm (s)

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 Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

255

Completion Date

August 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00133081

Other Study ID Numbers ^ICMJE

SITE

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

UMC Utrecht

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

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

Information Provided By

UMC Utrecht

Verification Date

March 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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