Phase 3
Completed N=56
Add on Lacosamide Versus High Dose Monotherapy
Source: ClinicalTrials.gov NCT01345058 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Participants Achieving Six Month Seizure Freedom — 47.4; 41.7 percentage of participants — p=0.49
Summary
This is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Six Month Seizure Freedom |
47.4; 41.7 | 0.49 |
| SECONDARY Number of Seizure-Free Days |
118.11; 114.0 | — |
| SECONDARY Time to First Seizure After Therapeutic Dose is Reached |
162.0; 116.5 | — |
| SECONDARY Retention Rate |
89; 80 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAE) |
11; 26 | — |
Eligibility Criteria
Inclusion Criteria
- Adults age 18 or older
- Determined to have had at least two partial seizures by an epilepsy specialist, or to have had a single partial seizure with clinical and/or laboratory evidence of a high seizure recurrence risk
- Monotherapy on levetiracetam less than or equal to 1500 mg/day for at least two weeks
- Breakthrough seizure while on stable dose (>5 days) of levetiracetam monotherapy regimen, not due to provocative factors (e.g. hypoglycemia, head trauma, missed medications)
Exclusion Criteria
- Clinical suspicion of nonepileptic psychogenic seizures or idiopathic generalized epilepsy
- Pregnant, child-bearing age not using contraception, or breast feeding
- Medical contraindication to adding lacosamide
- History of antiepileptic drug (AED) polytherapy
- Presence of a vagus nerve stimulator
- Creatinine clearance of less than 50 mL/min
- Blood pressure instability: pulse 100, systolic blood pressure (SBP) 180, clinically significant electrocardiogram (EKG) abnormality
- History of significant drug rash or anaphylactic reaction with antiepileptic drug
- Patients with progressive lesions (e.g. brain tumors)
Data sourced from ClinicalTrials.gov (NCT01345058). 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.