PURPOSE: To evaluate the efficacy and safety of @entity1771 (TPM) as add-on therapy in medically intractable @entity302 . METHODS: We used a multicenter double-blind placebo-controlled randomized parallel-group trial consisting of 12 weeks of baseline phase, 10 weeks of titration phase, and 8 weeks of stabilization phase. The primary efficacy variable was the median @entity410 frequency reduction rate (MSFRR), and the other efficacy variables included responder rate, @entity410 -free rate, and global evaluations by the @entity1 and the physician. The @entity1 should have @entity302 refractory to the maximally tolerable doses of one to two antiepileptic drugs (AEDs) and should have two or more episodes of clinical @entity410 every 4 weeks during the baseline phase. The target dose of study drugs was 600 mg/day. The study drugs were started at the initial dose of 50 mg/day and gradually increased to the target dose over a 10-week period. RESULTS: A total of 177 @entity1 was randomized into the TPM group (n = 91) and the placebo (PLC) group (n = 86). Baseline median @entity410 frequencies were 5.6 episodes/4 weeks in the TPM and the PLC groups. Among those who were randomized, 174 @entity1 (TPM, 89 @entity1 ; PLC, 85 @entity1 ) were available for the efficacy measurement by intention-to-treat analysis. The MSFRR was 51.3% for TPM and 9.1% for PLC, which was highly in favor of TPM (p = 0.0001). The responder rate was 50.6% for TPM and 12.9% for PLC (p = 0.001). Seven (7.9%) of 89 @entity1 taking TPM became @entity410 free compared with one (1.2%) of 85 @entity1 taking PLC (p = 0.004). The global evaluation greatly favored TPM (p = 0.001). The incidence of adverse events (AEs) was higher in the TPM (81.3%) than in the PLC (48.9%) group, with central nervous system (CNS)-related AEs being the most frequent. Among individual AEs, @entity448 (20.9%) and @entity490 or discomfort (20.9%) were the most common AEs in the TPM group. AEs precipitated early drop-out in seven (7.6%) @entity1 taking TPM and three (3.5%) @entity1 taking PLC. No serious systemic AEs were observed. CONCLUSIONS: TPM was highly effective and safe as add-on therapy in medically intractable @entity302 . Slower titration of TPM might be responsible for the lesser drop-out rate than previous trials, but the incidence of AEs was still high. The AE profile of TPM in Koreans was different from that in whites.

@entity1771 in medically intractable XXXX : double-blind placebo-controlled randomized parallel group trial. Korean Topiramate Study Group.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity410 :: ('MESH:D012640', 'Disease') :: ['seizure', 'seizures'] @entity448 :: ('MESH:D000855', 'Disease') :: ['anorexia'] @entity1771 :: ('MESH:C052342', 'Chemical') :: ['topiramate'] @entity302 :: ('MESH:D004827', 'Disease') :: ['partial epilepsies'] @entity490 :: ('MESH:D015746', 'Disease') :: ['abdominal pain']
@entity302 :: (MESH:D004827,Disease) :: ['partial epilepsies']
