Adjunctive levetiracetam in children, adolescents, and adults with primary generalized seizures: Open-label, noncomparative, multicenter, long-term follow-up study.

Hdl Handle:
http://hdl.handle.net/10147/207299
Title:
Adjunctive levetiracetam in children, adolescents, and adults with primary generalized seizures: Open-label, noncomparative, multicenter, long-term follow-up study.
Authors:
Delanty, Norman; Jones, John; Tonner, Francoise
Affiliation:
Division of Neurology, Beaumont Hospital, Dublin, Ireland UCB Pharma, Raleigh,, North Carolina, U.S.A.1 UCB Pharma, Brussels, Belgium1.
Citation:
Epilepsia. 2012 Jan;53(1):111-9. doi: 10.1111/j.1528-1167.2011.03300.x. Epub 2011, Nov 2.
Journal:
Epilepsia
Issue Date:
1-Feb-2012
URI:
http://hdl.handle.net/10147/207299
DOI:
10.1111/j.1528-1167.2011.03300.x
PubMed ID:
22050371
Abstract:
Purpose: To evaluate the long-term efficacy and tolerability of adjunctive levetiracetam (LEV) in patients with uncontrolled idiopathic generalized epilepsy (IGE). Methods: This phase III, open-label, long-term, follow-up study (N167; NCT00150748) enrolled patients (4 to <65 years) with primary generalized seizures (tonic-clonic, myoclonic, absence). Patients received adjunctive LEV at individualized doses (1,000-4,000 mg/day; 20-80 mg/kg/day for children/adolescents weighing <50 kg). Efficacy results are reported for all seizure types [intention-to-treat (ITT) population, N = 217] and subpopulations with tonic-clonic (n = 152), myoclonic (n = 121), and/or absence (n = 70) seizures at baseline. Key Findings: One hundred twenty-five (57.6%) of 217 patients were still receiving treatment at the end of the study. Mean (standard deviation, SD) LEV dose was 2,917.5 (562.9) mg/day. Median (Q1-Q3) exposure to LEV was 2.1 (1.5-2.8) years, and the maximum duration was 4.6 years. Most patients were taking one (124/217, 57.1%) or >/=2 (92/217, 42.4%) concomitant antiepileptic drugs (AEDs). Seizure freedom of >/=6 months (all seizure types; primary efficacy end point) was achieved by 122 (56.2%) of 217 patients, and 49 (22.6%) of 217 patients had complete seizure freedom. Seizure freedom of >/=6 months from tonic-clonic, myoclonic, and absence seizures was achieved by 95 (62.5%) of 152, 75 (62.0%) of 121, and 44 (62.9%) of 70 patients, respectively. Mean (SD) maximum seizure freedom duration was 371.7 (352.4) days. At least one treatment-emergent adverse event (TEAE) was reported by 165 (76%) of 217 patients; most TEAEs were mild/moderate in severity, with no indication of an increased incidence over time. Seventeen (7.8%) of 217 patients discontinued medication because of TEAEs. The most common psychiatric TEAEs were depression (16/217, 7.4%), insomnia (9/217, 4.1%), nervousness (8/217, 3.7%), and anxiety (7/217, 3.2%). Significance: Adjunctive LEV (range 1,000-4,000 mg/day) demonstrated efficacy as a long-term treatment for primary generalized seizures in children, adolescents, and adults with IGE, and was well tolerated.
Language:
eng
ISSN:
1528-1167 (Electronic); 0013-9580 (Linking)

Full metadata record

DC FieldValue Language
dc.contributor.authorDelanty, Normanen_GB
dc.contributor.authorJones, Johnen_GB
dc.contributor.authorTonner, Francoiseen_GB
dc.date.accessioned2012-02-01T10:04:18Z-
dc.date.available2012-02-01T10:04:18Z-
dc.date.issued2012-02-01T10:04:18Z-
dc.identifier.citationEpilepsia. 2012 Jan;53(1):111-9. doi: 10.1111/j.1528-1167.2011.03300.x. Epub 2011, Nov 2.en_GB
dc.identifier.issn1528-1167 (Electronic)en_GB
dc.identifier.issn0013-9580 (Linking)en_GB
dc.identifier.pmid22050371en_GB
dc.identifier.doi10.1111/j.1528-1167.2011.03300.xen_GB
dc.identifier.urihttp://hdl.handle.net/10147/207299-
dc.description.abstractPurpose: To evaluate the long-term efficacy and tolerability of adjunctive levetiracetam (LEV) in patients with uncontrolled idiopathic generalized epilepsy (IGE). Methods: This phase III, open-label, long-term, follow-up study (N167; NCT00150748) enrolled patients (4 to <65 years) with primary generalized seizures (tonic-clonic, myoclonic, absence). Patients received adjunctive LEV at individualized doses (1,000-4,000 mg/day; 20-80 mg/kg/day for children/adolescents weighing <50 kg). Efficacy results are reported for all seizure types [intention-to-treat (ITT) population, N = 217] and subpopulations with tonic-clonic (n = 152), myoclonic (n = 121), and/or absence (n = 70) seizures at baseline. Key Findings: One hundred twenty-five (57.6%) of 217 patients were still receiving treatment at the end of the study. Mean (standard deviation, SD) LEV dose was 2,917.5 (562.9) mg/day. Median (Q1-Q3) exposure to LEV was 2.1 (1.5-2.8) years, and the maximum duration was 4.6 years. Most patients were taking one (124/217, 57.1%) or >/=2 (92/217, 42.4%) concomitant antiepileptic drugs (AEDs). Seizure freedom of >/=6 months (all seizure types; primary efficacy end point) was achieved by 122 (56.2%) of 217 patients, and 49 (22.6%) of 217 patients had complete seizure freedom. Seizure freedom of >/=6 months from tonic-clonic, myoclonic, and absence seizures was achieved by 95 (62.5%) of 152, 75 (62.0%) of 121, and 44 (62.9%) of 70 patients, respectively. Mean (SD) maximum seizure freedom duration was 371.7 (352.4) days. At least one treatment-emergent adverse event (TEAE) was reported by 165 (76%) of 217 patients; most TEAEs were mild/moderate in severity, with no indication of an increased incidence over time. Seventeen (7.8%) of 217 patients discontinued medication because of TEAEs. The most common psychiatric TEAEs were depression (16/217, 7.4%), insomnia (9/217, 4.1%), nervousness (8/217, 3.7%), and anxiety (7/217, 3.2%). Significance: Adjunctive LEV (range 1,000-4,000 mg/day) demonstrated efficacy as a long-term treatment for primary generalized seizures in children, adolescents, and adults with IGE, and was well tolerated.en_GB
dc.language.isoengen_GB
dc.titleAdjunctive levetiracetam in children, adolescents, and adults with primary generalized seizures: Open-label, noncomparative, multicenter, long-term follow-up study.en_GB
dc.contributor.departmentDivision of Neurology, Beaumont Hospital, Dublin, Ireland UCB Pharma, Raleigh,, North Carolina, U.S.A.1 UCB Pharma, Brussels, Belgium1.en_GB
dc.identifier.journalEpilepsiaen_GB
dc.description.provinceLeinster-

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