Phase 2 N=39 Treatment

Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT01118962 ↗

Enrolled (actual)

Serious AEs

7.7%

Results posted

Dec 2013

Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) — 37 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lacosamide (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: UCB BIOSCIENCES, Inc.
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)	37	—
PRIMARY Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)	2	—

Summary

The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.

Eligibility Criteria

Inclusion Criteria

Subject completed the SP0961 (NCT01118949) study
Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator

Exclusion Criteria

Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01118962). 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.