Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures

Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0994 Study

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.

Study Overview

• Status: No longer available
• Conditions: Epilepsies, Partial
• Intervention / Treatment: Drug: Lacosamide

• Study Type: Expanded Access
• Expanded Access Type: Treatment IND/Protocol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient has completed the Termination Visit of SP0994 and has been treated with Lacosamide (LCM) monotherapy
• Patient is expected to benefit from participation in the Compassionate Use Program (CUP) with LCM monotherapy, in the opinion of the treating physician
• Patient is willing and able to comply with all program requirements
• Patient is informed of the details of this CUP, is given ample time and opportunity to ask questions and consider his/her participation in this CUP, and the patient or the legally authorized representative (LAR) has provided verbal consent to participate, and, if applicable to local regulations, has given written informed consent

Exclusion Criteria:

• Patient is receiving any investigational drugs or using any experimental devices in addition to LCM
• For countries where LCM is reimbursed: Patient requires another anti-epileptic drug (AED) for the treatment of seizures For countries where LCM is not reimbursed (or conditionally reimbursed: Belgium, Australia e.g.): Patient requires another AED for the treatment of seizures and qualifies for commercial LCM (and LCM is being reimbursed)
• Patient experienced emergence of a seizure type other than partial-onset or generalized tonic-clonic seizures, or occurrence of status epilepticus
• Patient developed second- or third-degree atrioventricular (AV) block or another clinically relevant change in medical condition (or electrocardiogram (ECG) or laboratory parameter)
• Patient having liver function test (LFT) results of transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) ≥3×ULN to <5×upper limit of normal (ULN)
• Patient has actual suicidal ideation or behavior
• Patient is experiencing an ongoing serious adverse event (SAE) and there is no expected benefit for him/her to continue on LCM treatment
• Female patient who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception (according to ICH guidance defined as those that result in a failure rate of less than 1 % per year when used consistently and correctly), unless sexually abstinent, for the duration of the study
• Patient was treated with carbamazepine controlled release (CBZ-CR) in SP0994

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: UCB Biopharma S.P.R.L.
• Investigators: Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsies, Partial; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: EP0072

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No