Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures
NCT03559673 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2019-10-31
Summary
The objective of this Compassionate Use Program (CUP) is to provide continued access to Lacosamide (LCM) for monotherapy use for patients who were receiving LCM in SP0993 and SP0994 at the time of study unblinding and close of SP0994, and who benefited from the treatment per investigator assessment.
Conditions
- Epilepsies, Partial
Interventions
- DRUG
-
Lacosamide
Patients will start on the individual Lacosamide (LCM) dose that they had reached at the completion of the previous monotherapy study. LCM will be administered orally twice daily in 2 divided doses.
Sponsors & Collaborators
-
UCB Biopharma S.P.R.L.
lead INDUSTRY
Principal Investigators
-
UCB Cares · 001 844 599 2273 (UCB)
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
More Related Trials
-
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
NCT01964560 ·Status: COMPLETED ·Phase: PHASE3
-
To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
NCT00552305 ·Status: COMPLETED ·Phase: PHASE2
-
Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
NCT01118949 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
NCT01921205 ·Status: COMPLETED ·Phase: PHASE3
-
Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
NCT00955357 ·Status: COMPLETED ·Phase: PHASE4
-
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
NCT02582866 ·Status: COMPLETED ·Phase: PHASE3
-
Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
NCT00530855 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures
NCT02477839 ·Status: COMPLETED ·Phase: PHASE3
-
An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy
NCT00938912 ·Status: COMPLETED ·Phase: PHASE2
-
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
NCT00522275 ·Status: COMPLETED ·Phase: PHASE3
-
Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
NCT00655551 ·Status: COMPLETED ·Phase: PHASE3
-
A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
NCT00938431 ·Status: COMPLETED ·Phase: PHASE2
-
Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
NCT00520741 ·Status: COMPLETED ·Phase: PHASE3
-
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
NCT01235403 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.
NCT02710890 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures
NCT01710657 ·Status: COMPLETED ·Phase: PHASE3
-
Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
NCT01243177 ·Status: COMPLETED ·Phase: PHASE3
-
Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures
NCT02192814 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
NCT02408523 ·Status: COMPLETED ·Phase: PHASE3
-
LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures
NCT00144872 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
NCT01832038 ·Status: COMPLETED ·Phase: PHASE3
-
Observational Retrospective Study of Effectivity and Tolerability in Patients With Lacosamide Medication
NCT01858870 ·Status: COMPLETED
-
Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
NCT01296880 ·Status: COMPLETED
-
A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures
NCT02124564 ·Status: COMPLETED ·Phase: PHASE3
-
Lacosamide Intravenous Injection for Emergency Termination of Status Epilepticus
NCT06966830 ·Status: NOT_YET_RECRUITING