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.

Abstract

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%.

• Authors: T Rentmeester, A Janssen, J Hulsman, F Scholtes, B van der Kleij, J Overweg, J Meijer, F de Beukelaar
• Journal: Epilepsy research (Epilepsy Res) 1991 May-Jun Vol. 9 Issue 1 Pg. 65-70 ISSN: 0920-1211 [Print] Netherlands
• PMID: 1909240 (Publication Type: Clinical Trial, Journal Article)

Chemical References

• Anticonvulsants
• Triazoles
• Carbamazepine
• loreclezole

Topics

• Adult
• Anticonvulsants (adverse effects, blood, therapeutic use)
• Carbamazepine (therapeutic use)
• Drug Interactions
• Epilepsies, Partial (drug therapy, physiopathology)
• Female
• Follow-Up Studies
• Humans
• Male
• Safety
• Time Factors
• Triazoles (adverse effects, blood, therapeutic use)