NCT00233012

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics safety and tolerability of topiramate in infants aged 1-24 months with refractory partial-onset seizures. Topiramate is an antiepileptic drug approved for use in adult and pediatric patients (aged 2 to 16 years) with refractory partial onset seizures (POS) with or without secondarily generalized seizures, primary generalized tonic clonic seizures, or Lennox-Gastaut syndrome (LGS).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2005

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 25, 2010

Status Verified

May 1, 2010

First QC Date

October 3, 2005

Last Update Submit

May 24, 2010

Conditions

Seizures

Keywords

Refractory partial-onset seizuresInfants aged 1-24 monthsPharmacokineticsTopiramate

Outcome Measures

Primary Outcomes (1)

  • Individual (each patient) and mean (each treatment) topiramate plasma concentration-time profiles.

Secondary Outcomes (1)

  • Incidence of adverse events throughout the study. Changes from pretreatment to the end of posttreatment phase in take-home records, clinical laboratory results, physical & neurologic examination results, ECGs, renal ultrasounds, vital sign measurements

Interventions

TopiramateDRUG

Eligibility Criteria

Age1 Month - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Regular enteral feeding (solid food
  • bottle- or cup-fed) with or without breastfeeding
  • weigh \>/=3.5 kilograms (kg) and \<15.5 kg
  • Length using an infant measuring table (heel to crown) must be = 49 cm
  • clinical or electroencephalographic (EEG) evidence of POS (simple or complex) with or without secondary generalization of at least 1 month in duration in infants \>6 months of age, or at least 2 weeks in duration in infants \<6 months of age
  • Multiple seizure types allowed as long as POS is present
  • Taking 1 or 2 concurrent marketed antiepileptic drugs (AEDs) for \>1 month for infants \>6 months of age and for \>2 weeks for infants \<6 months of age
  • the regimen of AEDs at entry must be considered inadequate in controlling seizures, after being optimized in the opinion of the investigator
  • Have had a computerized tomography or magnetic resonance imaging scan to confirm the absence of a progressive lesion such as a tumor, with the exception of lesions of tuberous sclerosis and Sturge-Weber syndrome, which are allowed.

You may not qualify if:

  • Exclusively breast-fed and cannot take oral liquid medication
  • Receives regular enteral feeding using gastrostomy, jejunostomy, or nasogastric tube
  • have surgically implanted and functioning vagus nerve stimulator
  • Have febrile seizures or seizures due to an acute medical illness
  • Have infantile seizures as a result of a correctable medical condition such as metabolic disturbance, toxic exposure, neoplasm, or active infection
  • History of nonepileptic seizures, either current or at any point in the past
  • Any progressive neurologic disorder, including malignancy, brain tumor, active central nervous system infection, demyelinating disease, or degenerative or progressive central nervous system disease with the exception of tuberous sclerosis and Sturge Weber syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ness S, Todd MJ, Wang S, Eerdekens M, Nye JS, Ford L. Adaptive behavior outcomes in infants treated with adjunctive topiramate. Pediatr Neurol. 2012 Jun;46(6):350-8. doi: 10.1016/j.pediatrneurol.2012.02.028.

    PMID: 22633629DERIVED

  • Puri V, Ness S, Sattaluri SJ, Wang S, Todd M, Yuen E, Eerdekens M, Nye JS, Manitpisitkul P, Shalayda K, Ford L. Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures. J Child Neurol. 2011 Oct;26(10):1271-83. doi: 10.1177/0883073811406982. Epub 2011 Jun 14.

    PMID: 21673279DERIVED

MeSH Terms

Conditions

Seizures

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 5, 2005

Study Start

June 1, 2005

Study Completion

October 1, 2007

Last Updated

May 25, 2010

Record last verified: 2010-05