Long-term adjunctive lacosamide treatment in patients with partial-onset seizures

on behalf of the SP774 study investigators

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Objective: To evaluate long-term (up to 5.5 years) safety, seizure reduction, and maintenance of efficacy of the antiepileptic drug (AED) lacosamide as adjunctive treatment in an open-label extension trial (SP774; ClinicalTrials.gov: NCT00515619). Methods: Three hundred and seventy-six adults with partial-onset seizures taking 1-3 AEDs enrolled following completion of a double-blind trial of adjunctive lacosamide. During open-label treatment, dosage of lacosamide (100-800 mg/day) and/or concomitant AEDs could be adjusted to optimize tolerability and seizure control. Results: Kaplan-Meier estimates of patient retention were 74.5% at 12 months, 52.9% at 36 months, and 40.6% at 60 months; median open-label treatment duration was 1183 days (~3.2 years). The most frequently reported treatment-emergent adverse events were dizziness (24.2%), headache (14.4%), diplopia (13.8%), and nasopharyngitis (13.8%); 9.0% of patients discontinued due to adverse events, most commonly dizziness (1.3%). Median percent reduction in 28-day seizure frequency from baseline of the double-blind trial was 49.9% overall, 55.4% for 1-year completers, and 62.3% for 3-year completers. Overall, 50.0% of patients were considered ≥50% responders (achieved ≥50% reduction in 28-day seizure frequency); 55.9% of 1-year completers and 63.0% of 3-year completers were ≥50% responders. Conclusion: In eligible patients who entered the open-label extension trial, lacosamide was generally well tolerated. For most patients within each yearly completer cohort, seizure reduction was maintained over time.

Original languageEnglish
Pages (from-to)136-144
Number of pages9
JournalActa Neurologica Scandinavica
Volume133
Issue number2
DOIs
Publication statusPublished - Feb 1 2016

Fingerprint

Seizures
Dizziness
Nasopharyngitis
Therapeutics
Diplopia
Kaplan-Meier Estimate
Anticonvulsants
Headache
lacosamide
Maintenance
Safety

Keywords

  • Lacosamide
  • Open label
  • Partial-onset seizures
  • Responders
  • Safety
  • Tolerability

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Long-term adjunctive lacosamide treatment in patients with partial-onset seizures. / on behalf of the SP774 study investigators.

In: Acta Neurologica Scandinavica, Vol. 133, No. 2, 01.02.2016, p. 136-144.

Research output: Contribution to journalArticle

on behalf of the SP774 study investigators. / Long-term adjunctive lacosamide treatment in patients with partial-onset seizures. In: Acta Neurologica Scandinavica. 2016 ; Vol. 133, No. 2. pp. 136-144.
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abstract = "Objective: To evaluate long-term (up to 5.5 years) safety, seizure reduction, and maintenance of efficacy of the antiepileptic drug (AED) lacosamide as adjunctive treatment in an open-label extension trial (SP774; ClinicalTrials.gov: NCT00515619). Methods: Three hundred and seventy-six adults with partial-onset seizures taking 1-3 AEDs enrolled following completion of a double-blind trial of adjunctive lacosamide. During open-label treatment, dosage of lacosamide (100-800 mg/day) and/or concomitant AEDs could be adjusted to optimize tolerability and seizure control. Results: Kaplan-Meier estimates of patient retention were 74.5{\%} at 12 months, 52.9{\%} at 36 months, and 40.6{\%} at 60 months; median open-label treatment duration was 1183 days (~3.2 years). The most frequently reported treatment-emergent adverse events were dizziness (24.2{\%}), headache (14.4{\%}), diplopia (13.8{\%}), and nasopharyngitis (13.8{\%}); 9.0{\%} of patients discontinued due to adverse events, most commonly dizziness (1.3{\%}). Median percent reduction in 28-day seizure frequency from baseline of the double-blind trial was 49.9{\%} overall, 55.4{\%} for 1-year completers, and 62.3{\%} for 3-year completers. Overall, 50.0{\%} of patients were considered ≥50{\%} responders (achieved ≥50{\%} reduction in 28-day seizure frequency); 55.9{\%} of 1-year completers and 63.0{\%} of 3-year completers were ≥50{\%} responders. Conclusion: In eligible patients who entered the open-label extension trial, lacosamide was generally well tolerated. For most patients within each yearly completer cohort, seizure reduction was maintained over time.",
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author = "{on behalf of the SP774 study investigators} and F. Rosenow and A. Kelemen and E. Ben-Menachem and C. Mcshea and J. Isojarvi and P. Doty and Sam Berkovic and Michelle Kiley and Terence O'Brien and Reutens, {David Charles} and Seneviratne, {Wijesekera Udaya} and Robinson, {Martin Kevin} and Schapel, {Graham John} and Somerville, {Ernest Robertson} and Tomislav Babic and Zdravka Poljakovic and Vida Demarin and Sanja Hajnsek and Michal Bar and Jindriska Buresova and Helena Hojdikova and Petr Marusic and Evzen Nespor and Ivan Rektor and Hana Vacovska and Jana Zarubova and Kaalviaainen, {Reetta K.} and Tapani Keraanen and Korpelainen, {Juha Tapani} and {Kaarina Lamusuo}, {Salla Liisi} and Tuula Nylund and Arielle Crespel and Philippe Derambure and Philippe Ryvlin and Franck Semah and Michel Tiberg{\'e} and Luc Valton and Stephan Arnold and Christoph Siebold and Martin Holtkamp and Bettina Schmitz and Meencke, {Heinz Joachim} and Holger Lerche and Michael Nitsche and Frithjof Tergau and P. Hal{\'a}sz and A. Kelemen and S. Komoly and I. Kond{\'a}kor and L. V{\'e}csei",
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T1 - Long-term adjunctive lacosamide treatment in patients with partial-onset seizures

AU - on behalf of the SP774 study investigators

AU - Rosenow, F.

AU - Kelemen, A.

AU - Ben-Menachem, E.

AU - Mcshea, C.

AU - Isojarvi, J.

AU - Doty, P.

AU - Berkovic, Sam

AU - Kiley, Michelle

AU - O'Brien, Terence

AU - Reutens, David Charles

AU - Seneviratne, Wijesekera Udaya

AU - Robinson, Martin Kevin

AU - Schapel, Graham John

AU - Somerville, Ernest Robertson

AU - Babic, Tomislav

AU - Poljakovic, Zdravka

AU - Demarin, Vida

AU - Hajnsek, Sanja

AU - Bar, Michal

AU - Buresova, Jindriska

AU - Hojdikova, Helena

AU - Marusic, Petr

AU - Nespor, Evzen

AU - Rektor, Ivan

AU - Vacovska, Hana

AU - Zarubova, Jana

AU - Kaalviaainen, Reetta K.

AU - Keraanen, Tapani

AU - Korpelainen, Juha Tapani

AU - Kaarina Lamusuo, Salla Liisi

AU - Nylund, Tuula

AU - Crespel, Arielle

AU - Derambure, Philippe

AU - Ryvlin, Philippe

AU - Semah, Franck

AU - Tibergé, Michel

AU - Valton, Luc

AU - Arnold, Stephan

AU - Siebold, Christoph

AU - Holtkamp, Martin

AU - Schmitz, Bettina

AU - Meencke, Heinz Joachim

AU - Lerche, Holger

AU - Nitsche, Michael

AU - Tergau, Frithjof

AU - Halász, P.

AU - Kelemen, A.

AU - Komoly, S.

AU - Kondákor, I.

AU - Vécsei, L.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - Objective: To evaluate long-term (up to 5.5 years) safety, seizure reduction, and maintenance of efficacy of the antiepileptic drug (AED) lacosamide as adjunctive treatment in an open-label extension trial (SP774; ClinicalTrials.gov: NCT00515619). Methods: Three hundred and seventy-six adults with partial-onset seizures taking 1-3 AEDs enrolled following completion of a double-blind trial of adjunctive lacosamide. During open-label treatment, dosage of lacosamide (100-800 mg/day) and/or concomitant AEDs could be adjusted to optimize tolerability and seizure control. Results: Kaplan-Meier estimates of patient retention were 74.5% at 12 months, 52.9% at 36 months, and 40.6% at 60 months; median open-label treatment duration was 1183 days (~3.2 years). The most frequently reported treatment-emergent adverse events were dizziness (24.2%), headache (14.4%), diplopia (13.8%), and nasopharyngitis (13.8%); 9.0% of patients discontinued due to adverse events, most commonly dizziness (1.3%). Median percent reduction in 28-day seizure frequency from baseline of the double-blind trial was 49.9% overall, 55.4% for 1-year completers, and 62.3% for 3-year completers. Overall, 50.0% of patients were considered ≥50% responders (achieved ≥50% reduction in 28-day seizure frequency); 55.9% of 1-year completers and 63.0% of 3-year completers were ≥50% responders. Conclusion: In eligible patients who entered the open-label extension trial, lacosamide was generally well tolerated. For most patients within each yearly completer cohort, seizure reduction was maintained over time.

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KW - Lacosamide

KW - Open label

KW - Partial-onset seizures

KW - Responders

KW - Safety

KW - Tolerability

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