Phase 3
Completed N=366
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
Epilepsies, Partial
Source: ClinicalTrials.gov NCT00772603 ↗
Enrolled (actual)
366
Serious AEs
6.6%
Results posted
Feb 2014
Primary outcomePrimary: PCH(T), ITT — -42.90; -38.20; -28.70 percentage of change — p==0.003
Summary
Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PCH(T), ITT |
-42.90; -38.20; -28.70 | =0.003 sig |
| SECONDARY PCH(M)- ITT |
-49.15; -35.30; -32.90 | =0.003 sig |
| SECONDARY Responder Rate, ITT |
50; 44; 34 | =0.018 sig |
| SECONDARY Seizure-Free Rates, ITT |
14; 6; 4 | =0.013 sig |
| SECONDARY Seizure Free Rate, ITT, (M) |
17; 4; 7 | =0.008 sig |
Eligibility Criteria
Inclusion Criteria
- Capable of complying with the study procedures.
- Able to provide written informed consent
- Male or female aged 18 to 65 years, inclusive.
- Diagnosis of partial onset seizures
- Minimum of three seizures per 28 days
- Receiving treatment with 1-3 AEDs
- Refractory to at least one AED
- No progressive neurological conditions by recent MRI/CT
- Adequate birth control in women of child-bearing potential
Exclusion Criteria
- Refractory to OXC for reasons of efficacy
- Recent status epilepticus
- Recent non-epileptic seizures
- Current diagnosis of major depression
- Recent suicidal plan or intent or more than one attempt
- Current use of oxcarbazepine, felbamate for 15mcg/mL or frequent need for rescue benzodiazepines
- Current use of sodium-lowering non-seizure medications.
- Clinically significant hepatic, renal, or cardiovascular function
- History of recent substance abuse
- Females who are pregnant or lactating.
- Hypersensitivity to OXC or related drugs
- Difficulty swallowing study medication
Data sourced from ClinicalTrials.gov (NCT00772603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.