Table 1.
Summary of key lacosamide clinical trials in POS
| Study | Design | Lacosamide treatment | Status |
|---|---|---|---|
| Phase IIb/III efficacy and safety registration studies with oral lacosamide as adjunctive therapy in adults with partial-onset seizures | |||
| SP66730 | Multicenter, multinational, double-blind, placebo-controlled, randomized, dose–response study | Adjunctive, oral tablet 200, 400, or 600 mg/day | Complete; manuscript published |
| SP75431 (NCT00136019) | Multicenter, randomized, double-blind, placebo-controlled, parallel-group study | Adjunctive, oral tablet 400 or 600 mg/day | Complete; manuscript published |
| SP75532 (NCT00220415) | Multicenter, international, randomized, double-blind, placebo-controlled, parallel-group study | Adjunctive, oral tablet 200 or 400 mg/day | Complete; manuscript published |
| EP0008 (NCT01710657) | Multicenter, double-blind, randomized, placebo-controlled, parallel-group study in Japanese and Chinese adults | Adjunctive, oral tablet 200 or 400 mg/day | Recruiting |
| Long-term safety studies with oral lacosamide as adjunctive therapy in adults with partial-onset seizures | |||
| SP61536 (NCT00552305) | Open-label, uncontrolled extension (up to 8 years) of SP667 | Adjunctive, oral tablet 100–800 mg/day | Complete |
| SP77437 (NCT00515619) | Open-label, uncontrolled extension (up to 5.5 years) of SP755 | Adjunctive, oral tablet 100–800 mg/day | Complete |
| SP75635 (NCT00522275) | Open-label, uncontrolled extension (up to 6 years) of SP754 | Adjunctive, oral tablet 100–800 mg/day | Complete; manuscript published |
| SP926 (NCT00655486) | Open-label, uncontrolled extension (up to 2 years) of SP925 | Adjunctive, oral tablet 100–800 mg/day | Complete |
| Phase II/III safety studies of IV lacosamide as replacement for oral lacosamide in adults with partial-onset seizures | |||
| SP61638 (NCT00800215) | Multicenter, randomized, double-blind, double-dummy, placebo-controlled, inpatient study | Adjunctive, oral tablet or IV infusion (30 or 60 min); daily dose equivalent to current daily dose in open-label extension trial (200–600 mg/day) | Complete; manuscript published |
| SP75723 (NCT00151879) | Multicenter, open-label, serial cohort study | Adjunctive, oral tablet or IV infusion (10, 15, or 30 min); daily dose equivalent to current daily dose in open-label extension trial (200–800 mg/day) | Complete; manuscript published |
| Safety and tolerability study of adjunctive lacosamide IV loading dose in lacosamide-naive adults with partial-onset seizures | |||
| SP92539 (NCT00655551) | Multicenter, open-label, sequential cohort, loading-dose study | Adjunctive, single IV loading dose followed 12 h later with oral tablet for 6.5 days | Complete; manuscript published |
| Safety and pharmacokinetic studies with oral lacosamide syrup as adjunctive therapy in children with partial-onset seizures | |||
| SP847 (NCT00938431) | Multicenter, open-label study | Adjunctive, oral solution (syrup) up to 12 mg/kg/day | Recruiting |
| SP848 (NCT00938912) | Multicenter, open-label extension study | Adjunctive, oral solution (syrup) 2–12 mg/kg/day or oral tablets 100–600 mg/day | Recruiting |
| SP1047 | Multicenter, open-label study in subjects 1–17 years of age | Varying doses as prescribed by treating physician | Recruiting |
| Phase III efficacy and safety studies of oral lacosamide as monotherapy in adults with partial-onset seizures | |||
| SP902/ALEX-MT(NCT00520741) | Multicenter, randomized, double-blind, historical-control study of conversion to lacosamide monotherapy | Conversion to monotherapy, oral tablet 300 or 400 mg/day | Complete |
| SP0993 (NCT01243177) | Multicenter, randomized, double-blind, double-dummy, positive-control study comparing lacosamide to controlled-release carbamazepine as initial monotherapy in adults with POS or general tonic–clonic seizures | Monotherapy, oral tablet 200–600 mg/day | Recruiting |
| Long-term safety studies of oral lacosamide as monotherapy in adults with partial-onset seizures | |||
| SP904 (NCT00530855) | Open-label extension (up to 2 years) of SP902 | Monotherapy, oral tablet 100–800 mg/day | Active; not recruiting |
| SP0994 (NCT01465997) | Double-blind extension (up to 3.5 years) of SP0993 | Monotherapy, oral tablet 200–600 mg/day | Recruiting |