OBJECTIVE: To explore the efficacy and tolerability of levetiracetam in medical treatment of trigeminal neuralgia. BACKGROUND: Antiepileptic drugs (AEDs) are considered as first-line treatment for trigeminal neuralgia, although their use is often limited due to incomplete efficacy and tolerability. Newer AEDs with improved safety profile may be useful in this disorder. METHODS:Patients suffering from trigeminal neuralgia (either primary or secondary) refractory to previous treatments were recruited to be treated withlevetiracetam (3-4 g/day) for 16 weeks as add-on therapy, after a 2-week baseline period. Rescue medication was allowed in both the baseline and treatment phases. The primary efficacy measure was the number of attacks per day. The patients' efficacy evaluation, the patients' global evaluation for both safety and efficacy, changes in the Hamilton Depression Scale, the Hamilton Anxiety Scale, and the Quality of Life Measure Short Form-36 were secondary parameters. RESULTS:Twenty-three patients were included in the analysis. After treatment and compared to the baseline phase, the number of daily attacks decreased by 62.4%. All secondary parameters changed significantly with the exception of the Quality of Life Measure Short Form-36 score. Seven patients withdrew from the study. Five patients (21.7%) reported side effects and 2 withdrew. CONCLUSIONS:Levetiracetam may be effective and safe in trigeminal neuralgia treatment. Confirmation in a randomized controlled study is needed.
RCT Entities:
OBJECTIVE: To explore the efficacy and tolerability of levetiracetam in medical treatment of trigeminal neuralgia. BACKGROUND: Antiepileptic drugs (AEDs) are considered as first-line treatment for trigeminal neuralgia, although their use is often limited due to incomplete efficacy and tolerability. Newer AEDs with improved safety profile may be useful in this disorder. METHODS:Patients suffering from trigeminal neuralgia (either primary or secondary) refractory to previous treatments were recruited to be treated with levetiracetam (3-4 g/day) for 16 weeks as add-on therapy, after a 2-week baseline period. Rescue medication was allowed in both the baseline and treatment phases. The primary efficacy measure was the number of attacks per day. The patients' efficacy evaluation, the patients' global evaluation for both safety and efficacy, changes in the Hamilton Depression Scale, the Hamilton Anxiety Scale, and the Quality of Life Measure Short Form-36 were secondary parameters. RESULTS: Twenty-three patients were included in the analysis. After treatment and compared to the baseline phase, the number of daily attacks decreased by 62.4%. All secondary parameters changed significantly with the exception of the Quality of Life Measure Short Form-36 score. Seven patients withdrew from the study. Five patients (21.7%) reported side effects and 2 withdrew. CONCLUSIONS:Levetiracetam may be effective and safe in trigeminal neuralgia treatment. Confirmation in a randomized controlled study is needed.