Phase 3
Completed N=322
Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
Source: ClinicalTrials.gov NCT00530855 ↗Enrolled (actual)
322
Serious AEs
17.4%
Results posted
Jun 2015
Primary outcomePrimary: Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study — 292 Participants
Summary
This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study |
292 | — |
| PRIMARY Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study |
479.1 | — |
| SECONDARY Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study |
296 | — |
| SECONDARY Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study |
22 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)
Exclusion Criteria
- Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)
Data sourced from ClinicalTrials.gov (NCT00530855). 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.