Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures

Journal of Child Neurology

Volumn 26, Issue 10, 2011, Pages 1271-1283

  Puri, Vinay ^a   Ness, Seth ^b   Sattaluri, Sita Jayalakshmi ^c   Wang, Steven ^b   Todd, Mike ^b   Yuen, Eric ^b   Eerdekens, Marielle ^d   Nye, Jeffrey S ^b   Manitpisitkul, Prasarn ^b   Shalayda, Kevin ^b   Ford, Lisa ^b  

^a Kentucky Neuroscience Research   (United States)

^b JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^c NIZAM'S INSTITUTE OF MEDICAL SCIENCES   (India)

^d JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

adjunctive topiramate; efficacy; long term tolerability; partial onset seizures

Indexed keywords

PLACEBO; TOPIRAMATE;

ACIDOSIS; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BODY HEIGHT; BODY WEIGHT; BRONCHITIS; BRONCHOSPASM; CONSTIPATION; CONTROLLED STUDY; CONVULSION; COUGHING; DEHYDRATION; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEVER; FOCAL EPILEPSY; GASTROENTERITIS; GROWTH RETARDATION; HEAD CIRCUMFERENCE; HUMAN; HYPERAMMONEMIA; INFANT; INSOMNIA; MALE; NERVOUSNESS; ONSET AGE; OTITIS MEDIA; PHARYNGITIS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; RHINITIS; SIDE EFFECT; SOMNOLENCE; SWEATING; TOOTH DISEASE; TREATMENT DURATION; VIRUS INFECTION; VOMITING; WEIGHT REDUCTION;

ANTICONVULSANTS; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; FRUCTOSE; HUMANS; INFANT; LONGITUDINAL STUDIES; MALE; SEIZURES; TREATMENT OUTCOME;

EID: 80054011467     PISSN: 08830738     EISSN: 17088283     Source Type: Journal    
DOI: 10.1177/0883073811406982     Document Type: Article

References (32)

1. Nordli DR. Diagnostic difficulty in infants and children. J Child Neurol. 2002 ; 17 (Suppl 1). S28 - S35
2. Neville BG. Epilepsy in childhood. BMJ. 1997 ; 315: 924-930
3. Kuzniecky RI, Mortati K. Practical strategies for switching to newer antiepileptic drugs. Rev Neurol Dis. 2005 ; 2: 186-198 (Pubitemid 43031286)
4. Wilfong AA. Monotherapy in children and infants. Neurology. 2007 ; 69: S17 - S22 (Pubitemid 350294668)
5. Shinnar S, Pellock J. The trials and tribulations of pediatric drug trials. Neurology. 2005 ; 65: 1348-1349 (Pubitemid 41552758)
6. TOPAMAXUS Prescribing Information [online]. www.topamax.com. Accessed March 18, 2009.
7. Ritter F, Glauser TA, Elterman RD, et al. Effectiveness, tolerability, and safety of topiramate in children with partial-onset seizures. Topiramate YP Study Group. Epilepsia. 2000 ; 41 (Suppl 1). S82 - S85 (Pubitemid 30202348)
8. Coppola G, Caliendo G, Terracciano MM, et al. Topiramate in refractory partial-onset seizures in children, adolescents and young adults: a multicentric open trial. Epilepsy Res. 2001 ; 43: 255-260 (Pubitemid 32204451)
9. Ormrod D, McClellan K. Topiramate: a review of its use in childhood epilepsy. Paediatr Drugs. 2001 ; 3: 293-319 (Pubitemid 32391810)
10. Watemberg N. Topiramate: a viewpoint by Nathan Watemberg, MD. CNS Drugs. 2003 ; 17: 993
11. Al Ajlouni S, Shorman A, Daoud AS. The efficacy and side effects of topiramate on refractory epilepsy in infants and young children: a multi-center clinical trial. Seizure. 2005 ; 14: 459-463 (Pubitemid 41548600)
12. Glauser TA, Dlugos DJ, Dodson WE, et al. Topiramate monotherapy in newly diagnosed epilepsy in children and adolescents. J Child Neurol. 2007 ; 22: 693-699
13. Zou LP, Lin Q, Qin J, et al. Topiramate Study Group evaluation of open-label topiramate as primary or adjunctive therapy in infantile spasms. Clin Neuropharmacol. 2008 ; 31: 86-92 (Pubitemid 351489334)
14. Watemberg N, Goldberg-Stern H, Ben-Zeev B, et al. Clinical experience with open-label topiramate use in infants younger than 2 years of age. J Child Neurol. 2003 ; 18: 258-262 (Pubitemid 36603623)
15. Pellock J. Managing pediatric epilepsy syndromes with new antiepileptic drugs. Pediatrics. 1999 ; 104: 1106-1116 (Pubitemid 29529187)
16. Valencia I, Fons C, Kothare SV, et al. Efficacy and tolerability of topiramate in children younger than 2 years old. J Child Neurol. 2005 ; 20: 667-669
17. NCT00233012. Johnson & Johnson Research & Development. A study of the pharmacokinetics, safety and tolerability of topiramate in infants (age 1-24 months) with refractory partial-onset seizures. www.clinicaltrials.gov/ct/ show/NCT00233012. Accessed October 2010.
18. Novotny E, Renfroe B, Yardi N, et al. A randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures. Neurology. 2010 ; 74: 714-720
19. Centers for Disease Control and Prevention: CDC growth charts. http://www.cdc.gov/nchs/about/major/nhanes/growthcharts/datafiles.html. Last updated September 2010. Accessed October 2010
20. Brodie M. Medical therapy of epilepsy: when to initiate treatment and when to combine?. J Neurol. 2005 ; 252: 125-130 (Pubitemid 40385583)
21. Jette N, Hemming K, Hutton JL, et al. Topiramate add-on for drug-resistant partial epilepsy. Cochrane Database Syst Rev.. 2008 ;:
22. Reiter E, Feucht M, Hauser E, et al. Changes in body mass index during long-term topiramate therapy in paediatric epilepsy patients-a retrospective analysis. Seizure. 2004 ; 13: 491-493
23. Takeoka M, Holmes GL, Thiele E, et al. Topiramate and metabolic acidosis in pediatric epilepsy. Epilepsia. 2001 ; 42: 387-392 (Pubitemid 32279651)
24. Ko CH, Kong CK. Topiramate-induced metabolic acidosis: report of two cases. Dev Med Child Neurol. 2001 ; 43: 701-704
25. Philippi H, Boor R, Reitter B. Topiramate and metabolic acidosis in infants and toddlers. Epilepsia. 2002 ; 43: 744-747 (Pubitemid 34774257)
26. Glauser T, Ayala R, Elterman RD, et al. Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures. Neurology. 2006 ; 66: 1654-1660 (Pubitemid 43964617)
27. Piña-Garza J, Levisohn P, Gucuyener K, et al. Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months. Neurology. 2008 ; 70: 2099-2108
28. May TW, Rambeck B, Jürgens U. Serum concentrations of topiramate in patients with epilepsy: influence of dose, age, and comedication. Ther Drug Monit. 2002 ; 24: 366-374 (Pubitemid 34553201)
29. Rosenfeld WE, Doose DR, Walker SA, et al. A study of topiramate pharmacokinetics and tolerability in children with epilepsy. Pediatr Neurol. 1999 ; 20: 339-344 (Pubitemid 29250178)
30. Ben-Menachem E. Weight issues for people with epilepsy-A review. Epilepsia. 2007 ; 48 (Suppl 9). 42-45 (Pubitemid 350198229)
31. Biton V, Mirza W, Montouris G, et al. Weight change associated with valproate and lamotrigine monotherapy in patients with epilepsy. Neurology. 2001 ; 56: 172-177 (Pubitemid 32095356)
32. Futagi Y, Otani K, Abe J. Growth suppression in children receiving acetazolamide with antiepileptic drugs. Pediatr Neurol. 1996 ; 15: 323-326 (Pubitemid 26418932)