Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233012
Status:
COMPLETED
Last Update Posted:
2010-05-25
First Post:
2005-10-03
Brief Title:
A Study of the Pharmacokinetics Safety and Tolerability of Topiramate in Infants Age 1-24 Months With Refractory Partial-onset Seizures
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Open-label OL Multicenter Study With OL Extension of the Pharmacokinetics and Safety of Topiramate Administered as Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy in Infants Aged 1-24 Months Inclusive With Refractory Partial-onset Seizures
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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-onset seizures POS The trial will evaluate the pharmacokinetics safety and tolerability of topiramate used as additional treatment in infants with refractory POS Topiramate is administered as liquid and sprinkles as adjunct additional treatment to concurrent anticonvulsant therapy The study will consist of 4 phases a pretreatment phase that includes screening up to 7 days and baseline 1 day an open-label treatment phase up to 6 weeks an open-label extension phase 54 weeks and a posttreatment phase up to 4 weeks Seizure diaries will be maintained throughout the study by the patients parents legally acceptable representatives or caregivers In the open-label treatment phase patients will be randomly assigned to 1 of 4 treatments topiramate 3 5 15 or 25 mgkg per day Venous blood samples four 1 milliliter mL samples will be collected on 2 days during the study to determine plasma concentration of topiramate Safety will be evaluated throughout the study by monitoring adverse events and by results from clinical laboratory tests serum chemistry venous ammonia hematology and urinalysis electrocardiograms ECGs vital sign measurements pulse and blood pressure physical examination neurologic examination Vineland Scales of Adaptive Behavior renal ultrasound assessments for adequate food and liquid intake hyperthermia oligohydrosis and rash and take-home records Liquid or sprinkles form of topiramate 3515or 25mgkg per day for 54 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None