Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
---|---|
Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00113815 |
The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).
Condition | Intervention | Phase |
---|---|---|
Epilepsy Seizures Partial Seizure Disorder |
Drug: topiramate Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, 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 (1-24 Months of Age) With Refractory Partial-Onset Seizures |
Enrollment: | 149 |
Study Start Date: | May 2005 |
Study Completion Date: | November 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
001: Experimental |
Drug: topiramate
5 mg/kg/day
|
002: Experimental |
Drug: topiramate
15 mg/kg/day
|
003: Experimental |
Drug: topiramate
25 mg/kg/day
|
004: Experimental |
Drug: placebo
placebo
|
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 post-treatment (taper and withdrawal) phase. The oral liquid formulation will also be assessed during this study, as it is investigational, unlike the marketed sprinkle formulation.
5, 15, 25 mg/kg/day of topriramate sprinkle and oral liquid formulation will be administered during the four phases of the study.
Ages Eligible for Study: | 1 Month to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( VP J&J PRD, Compound Development Team Leader ) |
Study ID Numbers: | CR002233 |
Study First Received: | June 10, 2005 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00113815 |
Health Authority: | United States: Food and Drug Administration |
Epilepsy Infants Topiramate Partial seizure disorder |
Epilepsies, Partial Signs and Symptoms Epilepsy Seizures |
Topiramate Neurologic Manifestations Central Nervous System Diseases Brain Diseases |
Anti-Obesity Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |