PURPOSE: The response to topiramate (TPM) as long-term adjunctive therapy was evaluated in patients with Lennox-Gastaut syndrome (LGS) in a long-term, open-label extension to a double-blind, placebo-controlled trial. METHODS: In 97 patients with LGS (mean age, 11 years), dosages of TPM and concomitant antiepileptic drugs (AEDs) were adjusted to optimal clinical response (mean TPM dosage, 10 mg/kg/day). RESULTS: For those patients who had completed 6 months of TPM therapy, drop attacks were reduced > or =50% in 55% of patients; 15% of patients had no drop attacks for > or =6 months at the last visit. After treatment up to 3+ years, 71% of patients who started open-label TPM were continuing therapy at the last visit. CONCLUSIONS: During long-term therapy, TPM is effective and well tolerated in controlling the treatment-resistant drop attacks and seizures associated with LGS.
RCT Entities:
PURPOSE: The response to topiramate (TPM) as long-term adjunctive therapy was evaluated in patients with Lennox-Gastaut syndrome (LGS) in a long-term, open-label extension to a double-blind, placebo-controlled trial. METHODS: In 97 patients with LGS (mean age, 11 years), dosages of TPM and concomitant antiepileptic drugs (AEDs) were adjusted to optimal clinical response (mean TPM dosage, 10 mg/kg/day). RESULTS: For those patients who had completed 6 months of TPM therapy, drop attacks were reduced > or =50% in 55% of patients; 15% of patients had no drop attacks for > or =6 months at the last visit. After treatment up to 3+ years, 71% of patients who started open-label TPM were continuing therapy at the last visit. CONCLUSIONS: During long-term therapy, TPM is effective and well tolerated in controlling the treatment-resistant drop attacks and seizures associated with LGS.