Long-term evaluation of the efficacy and safety of loreclezole as add-on therapy in patients with uncontrolled partial seizures: a 1-year open follow-up.
The effect and safety of loreclezole were evaluated during a long-term follow-up trial targeting higher plasma concentrations than those of the preceding controlled trial. The result is better than in the double-blind trial, in which loreclezole doses were administered to reach plasma concentrations of 1-2 mg/l and 6/32 patients (19%) of the verum group experienced a seizure reduction of 50% or more. None of the 30 placebo-treated patients experienced a similar decrease. At the end of the double-blind trial, 56 patients (29 from the original loreclezole and 27 from the original placebo group) elected to participate in the open follow-up trial. After 12 months' add-on treatment with loreclezole, mean plasma concentrations of 5.53 and 5.97 mg/l for the original placebo and loreclezole group were measured and the median decreases in seizure frequency were -44% and -40. At these concentrations, 22/56 patients (39%) showed a seizure reduction of at least 50%.
Rentmeester
T
T
Epilepsy Centre Kempenhaeghe, Heeze, The Netherlands.
Janssen
A
A
Hulsman
J
J
Scholtes
F
F
van der Kleij
B
B
Overweg
J
J
Meijer
J
J
de Beukelaar
F
F
D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D002220:Carbamazepine / Q000627:therapeutic use; D004347:Drug Interactions; D004828:Epilepsies, Partial / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D012449:Safety; D013997:Time Factors; D014230:Triazoles / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*
D000927:Anticonvulsants; D014230:Triazoles; D002220:Carbamazepine; C066440:loreclezole