Clinical trial
Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of…
NCT00113815 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry · Completed
Key facts
| NCT number | NCT00113815 |
|---|---|
| Title | Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures |
| 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 |
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Partial Seizure Disorder, Epilepsy, Seizures |
| Intervention type | Drug |
| Interventions | topiramate, placebo |
| Enrollment | 118 |
| Start date | May 1, 2005 |
| Primary completion | Jun 1, 2007 |
| Completion | Nov 1, 2007 |
| First posted | Jun 13, 2005 |
| Last update posted | Mar 26, 2014 |
| Countries | Argentina, Australia, Belgium, Canada, Chile, Finland, France, Hungary, India, Israel, Mexico, Netherlands and 11 more |
At a glance
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: