Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures

Completed · Phase 3

Conditions studied: Epilepsy

In brief

Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects \>= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 \[NCT02408523\] study.

Key facts

Study ID

NCT02408549

Run by

UCB BIOSCIENCES, Inc.

People needed

239

Starts

2015-08-03

Expected to finish

2023-03-30

Last updated by the study team

2023-12-14

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must have completed or be an eligible Baseline failure from the parent study (SP0982 [NCT02408523]). Note: Other subjects screened for SP0982 may be considered for roll-over to EP0012 if the investigator considers that the subject could benefit from treatment with open-label lacosamide (LCM) and based on prior discussion with and approval from the UCB Study Physician or representative

You may not qualify if…

• Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
• Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
• Subject has an active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%). For all subjects who entered EP0012 directly with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF). Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation.

Where it is running

• EP0012 8 — Santa Monica, California, United States
• Ep0012 31 — Colorado Springs, Colorado, United States
• Ep0012 42 — Loxahatchee Groves, Florida, United States
• Ep0012 13 — Panama City, Florida, United States
• EP0012 2 — Port Charlotte, Florida, United States
• Ep0012 15 — Boise, Idaho, United States
• Ep0012 21 — Peoria, Illinois, United States
• Ep0012 25 — Golden Valley, Minnesota, United States
• Ep0012 43 — New York, New York, United States
• Ep0012 53 — Austin, Texas, United States
• Ep0012 50 — Greenville, Texas, United States
• Ep0012 34 — Houston, Texas, United States
• Ep0012 38 — San Antonio, Texas, United States
• Ep0012 27 — Renton, Washington, United States
• Ep0012 23 — Madison, Wisconsin, United States
• Ep0012 980 — Chatswood, Australia
• Ep0012 985 — Heidelberg, Australia
• Ep0012 986 — Melbourne, Australia
• Ep0012 981 — Parkville, Australia
• Ep0012 181 — Curitiba, Brazil
• Ep0012 180 — Florianópolis, Brazil
• Ep0012 186 — Passo Fundo, Brazil
• Ep0012 185 — Porto Alegre, Brazil
• Ep0012 188 — Rio de Janeiro, Brazil
• EP0012 5 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.