Polytherapy and quality of life in young people with severe epilepsy

• Research type

  Research Study

• Full title

  THE IMPACT OF REDUCING ANTI-EPILEPTIC DRUG LOAD ON QUALITY OF LIFE IN YOUNG PEOPLE WITH REFRACTORY EPILEPSY

• Eudract number

  2007-003834-40

• ISRCTN Number

  N/A

• Research summary

  Epilepsy is the most commonchronic neurological disorder in childhood. About a quarter of all patientswith epilepsy will continue to have seizures despite trials of differentanti-epileptic drugs (AEDs) used either singly or in form of polytherapy(treatment with two or more drugs together administered at adequate doses).Although epilepsy can have a detrimental effect on an individual??s quality oflife (QOL) (i.e. general wellbeing and ability to enjoy life), any impairmentin QOL may be worsened by the effects of the drugs used to treat epilepsy. Theprimary aim of the study is to determine the effect of reducing the number ofAEDs on an individual??s QOL and seizure control in young people with difficultto control (refractory) epilepsy and who are on polytherapy. This is arandomised controlled trial. The period of research will last for 24 months;each participant being involved for six months only. We will recruit 64participants aged 6-21 who have refractory epilepsy and are on polytherapy. Theparticipants will be divided into two groups of 32 each, with reduction of oneof AEDs in the first group (withdrawal group) and no change to theirmedications in the second (control group). The carers of the participants willbe asked to complete several questionnaires on 2 occasions: the first time willbe immediately after entering the study (baseline assessment), and a second 6months after entering the study (follow-up assessment). These questionnairesaim to ??quantify? aspects related with quality of life, medication sideeffects, seizure severity, and behaviour. In addition, there will be a physicaland fine motor function assessment of all the participants. Weekly seizurefrequencies will be plotted for 6-12 months prior to inclusion in study andcompared with the frequency during the study period. Statistical analysis willthen be carried out to determine the possible clinical predictors of change inquality of life.

• REC name

  London - South East Research Ethics Committee

• REC reference

  08/H1102/83

• Date of REC Opinion

  31 Oct 2008

• REC opinion

  Further Information Favourable Opinion