A prospective multi-centre open label study of the use of levetiracetam as add-on treatment in patients with epilepsy and intellectual disabilities.

PURPOSE: To investigate the efficacy and safety of levetiracetam in adults with intellectual disabilities who have uncontrolled partial or generalised epilepsy.
METHODS: An open label prospective study compared seizure frequency, adverse effects, participant challenging behaviour, carers' concerns about epilepsy and perceived participant quality of life between a baseline observation prior to the use of levetiracetam and follow-up observations at 3, 6, 9 and 12 months afterwards. Challenging behaviour, carers' concerns about epilepsy and perceived quality of life were assessed using standardized measures.
RESULTS: Recruitment was low (n=42). Six participants did not enter the trial. Two participants withdrew at initiation of treatment, one with seizures worsening and one with a rash, and a further one later on with a rash; all were felt to be drug related. Three other participants withdrew for independent reasons. Twelve months follow-up was achieved for 26 participants (62%) and at least 6 months follow-up for 30 participants (71%). Median seizure frequency reduced from baseline levels of 4.2 per week to average post-intervention levels of 2.2 for the 30 participants (z=-2.53, p<.05). No overall change in challenging behaviour was found, although increases in behaviour problems were reported for a minority. Patient concerns about seizures and medical treatment declined and perceived quality of life relating to seizure severity improved whilst that related to behaviour deteriorated. Increased adverse effects were reported immediately after initiation of levetiracetam but declined towards baseline levels by study completion. DISCUSSION: Conclusions must remain tentative due to methodological weaknesses. Further investigation of the possible changes found here within a controlled study is merited.