Trials / Approved For Marketing
Approved For MarketingNCT00918424
Long Term Study of the Safety of OXC XR as in Pediatric Epilepsy Subjects
Long Term Multiple Dose, Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of OXC XR as Adjunctive Therapy in Pediatric Subjects With Refractory Partial Epilepsy
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Supernus Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
Follow-on study to continue evaluation of the safety of OXC XR as adjunctive therapy in pediatric epilepsy
Detailed description
Pediatric patients with partial onset epilepsy enrolled in a pharmacokinetic study of OXC XR were allowed to continue treatment with the investigational drug in this extensión study. The primary interest was in assessing the safety of treatment with OXC XR over a period of months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxcarbazepine Extended Release | OXC XR is a once-daily formulation of oxcarbazepine and is given at the same dosage levels. |
Timeline
- Start date
- 2009-06-01
- First posted
- 2009-06-11
- Last updated
- 2017-05-09
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00918424. Inclusion in this directory is not an endorsement.