The purpose of this study is to assess whether changing antiepileptic medication can reduce side effects and improve 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 IV

Further Study Details: 

Primary Outcomes: Complaints (questionnaire) at 7 and 13 months
Secondary Outcomes: Quality of Life (Qolie-10) at 7 and 13 months
Expected Total Enrollment:  255

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 adjust 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Cees A van Donselaar, MD PhD,  Study Director,  UMC Utrecht   
Sabine G Uijl, MSc,  Principal Investigator,  UMC Utrecht   
Albert P Aldenkamp, PhD,  Principal Investigator,  AZM Maastricht   
Cuno SP Uiterwaal, PhD,  Principal Investigator,  UMC Utrecht   

Study ID Numbers:  SITE
Last Updated:  August 19, 2005
Record first received:  August 17, 2005
ClinicalTrials.gov Identifier:  NCT00133081
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-09-13