Study to Improve the Treatment of Epilepsy (SITE)

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00133081
• Other study ID #: SITE
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 17, 2005
• Last updated: October 20, 2005
• Start date: October 2002
• Est. completion date: August 2006

Study information

• Verified date: March 2004
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 255
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• All registered antiepileptic drugs

Locations

Country	Name	City	State
Netherlands	Hospital Gooi-Noord	Blaricum	Noord Holland
Netherlands	Catharina Hospital	Eindhoven	Noord Brabant
Netherlands	Oosterschelde Hospital	Goes	Zeeland
Netherlands	AZM	Maastricht	Limburg
Netherlands	MCRZ	Rotterdam	Zuid Holland
Netherlands	MC Haaglanden	The Hague	Zuid Holland

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complaints (questionnaire) at 7 and 13 months
Secondary	Quality of Life (Qolie-10) at 7 and 13 months