Status:
COMPLETED
A Study of the Pharmacokinetics, Safety and Tolerability of Topiramate in Infants (Age 1-24 Months) With Refractory Partial-onset Seizures
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Seizures
Eligibility:
All Genders
1-24 years
Phase:
PHASE1
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 d...
Detailed Description
This is a open-label, randomized (patients are assigned different treatments based on chance), dose comparison, multicenter study of topiramate in infants of age 1-24 months with refractory partial-on...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00233012
Start Date
June 1 2005
End Date
October 1 2007
Last Update
May 25 2010
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