Table 1. Characteristics of included studies.
| First author & Publication year | Methodologic Quality | Patients | Intervention & comparator | Outcomes | Funding | ||
|---|---|---|---|---|---|---|---|
| N | Characteristics | Primary | Secondary | ||||
| Ben-Menachem et al. (2007) | Adequate sequence generation*; AC; Blinding of patients, physicians, outcome assessors and data collectors; not ITT; incomplete reporting of pre-specified outcomes; follow-up to 18 weeks |
421 |
Mean age (SD) 39.9 (11.3) Gender: 54% female Concomitant AEDs: 84% of the population were taking 2 AEDs at baseline, the rest were on 1 AED Median seizure frequency per 28 days across all treatment groups during the baseline period: 12 |
• Lacosamide 100 mg PO BID • Lacosamide 200 mg PO BID • Lacosamide 300 mg PO BID • Placebo PO BID Duration of treatment: 18 weeks (after 8 week baseline monitoring - 6 week dose-titration & 12 week |
• Change in seizure frequency per 28 days from baseline to maintenance • 50 % responder rate Outcomes assessed at: Weeks 0 & 18 |
• Adverse event (AE) data: including serious adverse events, and discontinuation due to AEs • Achievement of seizure-free status Efficacy outcomes assessed at: weeks 0 & 18 • QOL scales (CGIC & QOLIE-31 – only in UK & USA) assessed at Week 0, 6, & 18 • Adverse effects (assessed Weekly 0–6 weeks and 10, 14 and 18 weeks) |
Schwarz Biosciences Inc. |
| Chung et al. (2010b) | Adequate sequence generation; AC; Blinding of patients, physicians, outcome assessors and data collectors; not ITT; incomplete reporting of pre-specified outcomes follow-up to 18 weeks | 405 |
Mean Age (SD): 38.3 (12.1) Gender: 50.6% female Concomitant AEDs: Throughout the trial 82.1% were taking 2–3 concomitant AEDs Median seizure frequency per 28 days across all treatment groups during the baseline period: P 15.0 L400 11.5 L600 16.5 |
• Lacosamide 200 mg PO BID • Lacosamide 300 mg PO BID • Placebo PO BID Duration of treatment: 18 weeks (after 8 week baseline monitoring - 6 week titration & 12 week maintenance phase) |
• Change in seizure frequency per 28 days from baseline to maintenance • 50 % responder rate Outcomes assessed at: Week 0 & 18 |
• Adverse event (AE) data: including serious adverse events, and discontinuation due to AEs • % change in seizure frequency per 28 days from baseline to maintenance • 75% responder rate (the proportion of patients who experienced a 75% or greater reduction in seizure frequency from baseline to maintenance • Number & proportion of patients achieving seizure-free status throughout the maintenance period for patients completing the maintenance period and having complete efficacy data • Change in seizure frequency and 50% responder rate differentiated by seizure type •Adverse effects Outcomes assessed at: weeks 0 & 18 |
Schwarz Biosciences Inc., UCB Group |
| Halász et al. (2009) | Adequate sequence generation; AC; Blinding of patients, physicians, outcome assessors and data collectors; not ITT, incomplete reporting of pre-specified outcomes, follow-up to 16 weeks |
485 |
Mean Age (SD): 37.8 (11.9) Gender: 48.5% female Concomitant AEDs: 37% were taking 3 AEDs, 50% were taking 2 AEDs and 13% were taking 1 AED in addition to the trial medication Median seizure frequency per 28 days across all treatment groups during the baseline period: P 9.9 L200 11.5 L400 10.3 |
• Lacosamide 100 mg PO BID • Lacosamide 200 mg PO BID • Placebo PO BID Duration of treatment: 16 weeks (after 8 week baseline - 4 week titration and 12 week maintenance phase) |
• Change in seizure frequency per 28 days from baseline to maintenance • 50 % responder rate Outcomes assessed at: weeks 0 & 16 |
• Number & Proportion of patients achieving seizure-free status through the maintenance period for patients completing the maintenance period • Proportion of seizure-free days during the maintenance period for patients entering the maintenance period Efficacy Outcomes assessed at: weeks 0 & 16 •Adverse effects Outcomes assessed: weekly 0–16 weeks • QOL scores (PGIC, CGIC, SSS, QOLIE-31) QOL Outcomes assessed at: weeks 0 & 18 |
UCB Group |
Notes.
AC = allocation concealed, ITT = intention-to-treat analysis; N = total number of patients randomized; P = placebo; PO = oral; BID = twice daily; L200 = lacosamide 200 mg/day; L400 = lacosamide 400 mg/day; L600 = lacosamide 600 mg/day; CGIC = Clinical Global Impression of Change score; QOL – quality of life; QOLIE-31 = quality of life in epilepsy; PGIC = Patient’s Global Impression of Change Score; SSS = seizure severity scale.
*
Randomization method or details not provided by author/manufacturer.