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

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ClinicalTrials.gov Identifier: NCT03559673

Expanded Access Status : No longer available

First Posted : June 18, 2018

Last Update Posted : October 31, 2019

Sponsor:

Information provided by (Responsible Party):

UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Epilepsies, Partial	Drug: Lacosamide

Study Design

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Study Type :	Expanded Access
Expanded Access Type :	Treatment IND/Protocol
	See clinical trials of the intervention/treatment in this expanded access record.
Official Title:	Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0994 Study

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Pyridoxal 5'-phosphate-dependent epilepsy Autosomal dominant partial epilepsy with auditory features

MedlinePlus related topics: Seizures

Drug Information available for: Lacosamide

U.S. FDA: Expanded Access (Compassionate Use)

U.S. FDA Resources

Interventions

Intervention Details:

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.

Other Name: Vimpat

Eligibility Criteria

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Ages Eligible for Study:	16 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559673

Sponsors and Collaborators

UCB Biopharma S.P.R.L.

Investigators

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Study Director:	UCB Cares	001 844 599 2273 (UCB)

More Information

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Responsible Party:	UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier:	NCT03559673
Other Study ID Numbers:	EP0072
First Posted:	June 18, 2018 Key Record Dates
Last Update Posted:	October 31, 2019
Last Verified:	October 2019

Additional relevant MeSH terms:

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Seizures Epilepsies, Partial Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations	Lacosamide Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

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