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Study to Improve the Treatment of Epilepsy (SITE)

NCT ID: NCT00133081

Last Updated: 2005-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2006-08-31

Brief Summary

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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

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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.

Conditions

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Epilepsy

Keywords

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epilepsy antiepileptic drugs side effects quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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All registered antiepileptic drugs

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Principal Investigators

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Cees A van Donselaar, MD PhD

Role: STUDY_DIRECTOR

UMC Utrecht

Sabine G Uijl, MSc

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Albert P Aldenkamp, PhD

Role: PRINCIPAL_INVESTIGATOR

AZM Maastricht

Cuno SP Uiterwaal, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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AZM

Maastricht, Limburg, Netherlands

Site Status

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Site Status

Hospital Gooi-Noord

Blaricum, North Holland, Netherlands

Site Status

MCRZ

Rotterdam, South Holland, Netherlands

Site Status

MC Haaglanden

The Hague, South Holland, Netherlands

Site Status

Oosterschelde Hospital

Goes, Zeeland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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SITE

Identifier Type: -

Identifier Source: org_study_id