Abstract
Objective: To compare the safety and efficacy of add-on lamotrigine and placebo in the treatment of children and adolescents with partial seizures. Background: Add-on and monotherapy lamotrigine is safe and effective in adults with partial seizures, and reports of preliminary uncontrolled trials suggest similar benefits in children. Methods: We studied 201 children with diagnoses of partial seizures of any subtype currently receiving stable conventional regimens of antiepileptic therapy at 40 study sites in the United States and France. After a baseline observation period (to confirm that more than four seizures occurred in each of two consecutive 4-week periods), patients were randomized to add-on lamotrigine or placebo therapy. A 6-week dose-escalation period was followed by a 12-week maintenance period. Results: Compared with placebo, lamotrigine significantly reduced the frequency of all partial seizures and the frequency of secondarily generalized partial seizures in these treatment-resistant patients. The most commonly reported adverse events in the lamotrigine-treated patients were vomiting, somnolence, and infection; the frequency of these and other adverse events was similar to that in the placebo-treated group, with the exception of ataxia, dizziness, tremor, and nausea, which were more frequent in the lamotrigine-treated group. The frequency of withdrawals for adverse events was similar between groups. Two patients were hospitalized for skin rash, which resolved after discontinuation of lamotrigine therapy. Conclusions: Lamotrigine was effective for the adjunctive treatment of partial seizures in children and demonstrated an acceptable safety profile.
| Original language | English |
|---|---|
| Pages (from-to) | 1724-1731 |
| Number of pages | 8 |
| Journal | Neurology |
| Volume | 53 |
| Issue number | 8 |
| State | Published - Nov 10 1999 |
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Keywords
- Epilepsy
- Lamotrigine
- Partial seizures
- Pediatric
ASJC Scopus subject areas
- Neuroscience(all)
Cite this
A placebo-controlled trial of lamotrigine add-on therapy for partial seizures in children. / Duchowny, M.; Pellock, J. M.; Graf, W. D.; Billard, C.; Gilman, J.; Casale, E.; Womble, G.; Risner, M.; Manasco, P.
In: Neurology, Vol. 53, No. 8, 10.11.1999, p. 1724-1731.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A placebo-controlled trial of lamotrigine add-on therapy for partial seizures in children
AU - Duchowny, M.
AU - Pellock, J. M.
AU - Graf, W. D.
AU - Billard, C.
AU - Gilman, J.
AU - Casale, E.
AU - Womble, G.
AU - Risner, M.
AU - Manasco, P.
PY - 1999/11/10
Y1 - 1999/11/10
N2 - Objective: To compare the safety and efficacy of add-on lamotrigine and placebo in the treatment of children and adolescents with partial seizures. Background: Add-on and monotherapy lamotrigine is safe and effective in adults with partial seizures, and reports of preliminary uncontrolled trials suggest similar benefits in children. Methods: We studied 201 children with diagnoses of partial seizures of any subtype currently receiving stable conventional regimens of antiepileptic therapy at 40 study sites in the United States and France. After a baseline observation period (to confirm that more than four seizures occurred in each of two consecutive 4-week periods), patients were randomized to add-on lamotrigine or placebo therapy. A 6-week dose-escalation period was followed by a 12-week maintenance period. Results: Compared with placebo, lamotrigine significantly reduced the frequency of all partial seizures and the frequency of secondarily generalized partial seizures in these treatment-resistant patients. The most commonly reported adverse events in the lamotrigine-treated patients were vomiting, somnolence, and infection; the frequency of these and other adverse events was similar to that in the placebo-treated group, with the exception of ataxia, dizziness, tremor, and nausea, which were more frequent in the lamotrigine-treated group. The frequency of withdrawals for adverse events was similar between groups. Two patients were hospitalized for skin rash, which resolved after discontinuation of lamotrigine therapy. Conclusions: Lamotrigine was effective for the adjunctive treatment of partial seizures in children and demonstrated an acceptable safety profile.
AB - Objective: To compare the safety and efficacy of add-on lamotrigine and placebo in the treatment of children and adolescents with partial seizures. Background: Add-on and monotherapy lamotrigine is safe and effective in adults with partial seizures, and reports of preliminary uncontrolled trials suggest similar benefits in children. Methods: We studied 201 children with diagnoses of partial seizures of any subtype currently receiving stable conventional regimens of antiepileptic therapy at 40 study sites in the United States and France. After a baseline observation period (to confirm that more than four seizures occurred in each of two consecutive 4-week periods), patients were randomized to add-on lamotrigine or placebo therapy. A 6-week dose-escalation period was followed by a 12-week maintenance period. Results: Compared with placebo, lamotrigine significantly reduced the frequency of all partial seizures and the frequency of secondarily generalized partial seizures in these treatment-resistant patients. The most commonly reported adverse events in the lamotrigine-treated patients were vomiting, somnolence, and infection; the frequency of these and other adverse events was similar to that in the placebo-treated group, with the exception of ataxia, dizziness, tremor, and nausea, which were more frequent in the lamotrigine-treated group. The frequency of withdrawals for adverse events was similar between groups. Two patients were hospitalized for skin rash, which resolved after discontinuation of lamotrigine therapy. Conclusions: Lamotrigine was effective for the adjunctive treatment of partial seizures in children and demonstrated an acceptable safety profile.
KW - Epilepsy
KW - Lamotrigine
KW - Partial seizures
KW - Pediatric
UR - http://www.scopus.com/inward/record.url?scp=0033544351&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0033544351&partnerID=8YFLogxK
M3 - Article
C2 - 10563619
AN - SCOPUS:0033544351
VL - 53
SP - 1724
EP - 1731
JO - Neurology
JF - Neurology
SN - 0028-3878
IS - 8
ER -