Clobazam is equally safe and efficacious for seizures associated with Lennox-Gastaut syndrome across different age groups: Post hoc analyses of short- and long-term clinical trial results.
The peak age at onset of Lennox-Gastaut syndrome (LGS) is between 3 and 5years. Patients with LGS frequently experience multiple types of treatment-refractory seizures and require lifelong therapy with several antiepileptic drugs. Here, post hoc analyses of clinical trials (phase III trial OV-1012 and open-label extension trial OV-1004) provide short- and long-term efficacy and safety data of adjunctive clobazam in patients with LGS stratified by age at baseline (≥2 to <12years, ≥12 to <17years, and ≥17years). In OV-1012, 301 patients were screened, 238 were randomized, 217 comprised the modified intention-to-treat population, and 177 completed the study. A total of 267/306 patients (61 of 68 from phase II trial OV-1002 and 206 of 238 from phase III trial OV-1012) entered the open-label extension trial. Demographics and clinical characteristics were similar between different age groups in OV-1012 and OV-1004. No differences in efficacy or adverse events were observed across age groups in OV-1012 and OV-1004. The results of these post hoc analyses show that adjunctive clobazam over the short and longterm was similarly effective and well-tolerated in both pediatric and adult patients with LGS.
Baylor College of Medicine/Children's Hospital of San Antonio, San Antonio, TX, USA. Electronic address: ytng@bcm.edu.
Yu-Tze
YT
Ng
Children's National Medical Center, Washington, DC, USA.
Joan
J
Conry
Children's Hospital Los Angeles, Los Angeles, CA, USA.
Wendy G
WG
Mitchell
Alberta Children's Hospital, Calgary, Alberta, Canada.
Jeffrey
J
Buchhalter
Lundbeck LLC, Deerfield, IL, USA.
Jouko
J
Isojarvi
Lundbeck LLC, Deerfield, IL, USA.
Deborah
D
Lee
Lundbeck LLC, Deerfield, IL, USA.
Rebecca
R
Drummond
Barrow Neurological Institute, Phoenix, AZ, USA.
Steve
S
Chung
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000927:Anticonvulsants / Q000009:adverse effects / Q000494:pharmacology*; D001569:Benzodiazepines / Q000009:adverse effects / Q000494:pharmacology*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D000078306:Clobazam; D005260:Female; D006801:Humans; D065768:Lennox Gastaut Syndrome / Q000188:drug therapy*; D008297:Male; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*
D000927:Anticonvulsants; D001569:Benzodiazepines; D000078306:Clobazam
Age groups; Clobazam; Drop seizures; Lennox–Gastaut syndrome; Post hoc analyses; Total seizures