Phase 3
N=436
Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
Epilepsy · Partial Seizures
Bottom Line
View on ClinicalTrials.gov: NCT01954121 ↗Enrolled (actual)
436
Serious AEs
4.6%
Results posted
Aug 2016
Primary outcome: Primary: Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period — 47.3; 68.4 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Levetiracetam (Drug); Carbamazepine (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- UCB Pharma SA
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period |
47.3; 68.4 | — |
| SECONDARY Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period |
48.4; 70.2 | — |
| SECONDARY Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period |
88; 45 | — |
| SECONDARY Time to First Seizure During the Evaluation Period |
87; 39 | — |
| SECONDARY Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug |
97; 57 | — |
Summary
To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset Seizures (POS).
Eligibility Criteria
Inclusion Criteria
- Subject is of Chinese origin and ≥ 16 years of age
- Subject is newly or recently diagnosed with Epilepsy, having experienced unprovoked Partial-Onset Seizures (POS)
- Subject has experienced at least 2 unprovoked seizures in the year preceding randomization, of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization
- Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or brain Magnetic Resonance Imaging (MRI) scan consistent with a diagnosis of Epilepsy with POS
Exclusion Criteria
- Subject tests positive for human leukocyte antigen major histocompatibility complex, class I,B (HLA-B)* 1502 allele
- Subject has a history or presence of seizures of other types than Partial-Onset Seizures (POS)
- Subject has only experienced type IA nonmotor seizures
- Subject has a history or presence of seizures occurring only in clustered patterns
- Subject has a history of clinical or Electroencephalogram (EEG) findings suggestive of Idiopathic Generalized Epilepsy prior to randomization
- Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures
- Subject has a history of Status Epilepticus
Data sourced from ClinicalTrials.gov (NCT01954121). 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.