Not Signed In -
Seizures |
Seizure |
Clinical Trial: Topiramate as Adjunctive Therapy in Infants 1-23 Months for the Control of Partial Onset Seizures
This study is currently recruiting patients.
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Purpose
This is a world wide, multicenter, randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety and efficacy of 3 target doses (5, 15, and 25 mg/kg/day) of topiramate compared with placebo as an adjunct therapy in infants with refractory partial onset seizures (POS). There are 4 phases to the study, a screening phase of 3 days, a double blind treatment phase of 20 days, a one year open label extension phase and a posttreatment (taper and withdrawal) phase. The oral liquid formulation will also be assessed during this study, as it is investigational, unlike the marketed sprinkle formulation.
| Condition | Intervention | Phase |
|---|---|---|
| Partial Seizure Disorder Epilepsy Seizures | Drug: topiramate | Phase III |
MedlinePlus related topics: Epilepsy; Seizures
Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-23 Months of Age, Inclusive) With Refractory Partial-Onset Seizures, With Open-Label Extension
Eligibility
Ages Eligible for Study: 1 Month - 23 Months, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- 1-23 months, inclusive
- Concurrent 1 or 2 antiepileptic drugs
- Receiving regular enteral feedings
- Weigh between 3.5 and 15 kg
- Clinical or EEG evidence of simple or complex POS
Exclusion Criteria:
- Exclusively breast fed and cannot take medicine by mouth
- Surgically implanted and functioning vagus nerve stimulator
- Renal stones
- Medically uncontrolled illnesses or conditions
- Infantile seizures as a result of a correctable medical condition
- Progressive neurologic disorder
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00113815
Florida
Child Neurology Center of N.W. Florida, Pensacola, Florida, 32561, United States; Recruiting
Study Coordinator 850-484-6060
Wisconsin
Dean Medical Center, Madison, Wisconsin, 53715, United States; Recruiting
Study Coordinator 608-252-8341
More Information
Study ID Numbers: TOPMAT-PEP-3001
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 10, 2005
ClinicalTrials.gov Identifier: NCT00113815
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 10, 2005
ClinicalTrials.gov Identifier: NCT00113815
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05
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