Phase 3
Completed N=425
Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
Source: ClinicalTrials.gov NCT00520741 ↗Enrolled (actual)
425
Serious AEs
5.9%
Results posted
Apr 2014
Primary outcomePrimary: Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s) — 30.0 percentage of subjects
Summary
The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s) |
30.0 | — |
| SECONDARY Time to First Occurrence of Any Exit Event During The Maintenance Period |
39; 45.0 | — |
| SECONDARY Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period |
32.3 | — |
| SECONDARY Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12) |
71; 71 | — |
| SECONDARY Clinical Global Impression of Change (CGIC) From Baseline To Last Visit |
21; 56; 33; 116; 18; 42 | — |
| SECONDARY Patient's Global Impression of Change (PGIC) From Baseline To Last Visit |
24; 81; 33; 93; 15; 37 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and or Complex Partial Seizures (with or without secondary generalization)
- Must be experiencing 2 to 40 seizures per 28-day period
- Stable dose of 1 or 2 marketed antiepileptic drugs
- Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA product label at screening
Exclusion Criteria
- Subject has a history of primary generalized or unclassified seizures
- Seizure disorder primarily characterized by isolated auras
- History of status epilepticus
- Seizures that are uncountable due to clustering
- Has greater than 5 seizures/day
- Subjects taking Benzodiazepines, Phenobarbital or Primidone
- Subject has Vagus Nerve Stimulation (VNS)
- Significant medical or psychiatric condition
- History of alcohol or drug abuse
- History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997
Data sourced from ClinicalTrials.gov (NCT00520741). 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.