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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB, Inc.

ClinicalTrials.gov Identifier:

NCT01118962

First received: May 5, 2010

Last updated: October 26, 2012

Last verified: October 2012

History of Changes

Purpose

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 to continue to receive lacosamide.

Condition	Intervention	Phase
Epilepsy	Drug: Lacosamide	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Long-Term Oral Lacosamide for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Lacosamide

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Number of participants with treatment-emergent adverse events (TEAEs) during the 56-week treatment phase [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
Number of participants withdrawn from the study due to treatment-emergent adverse events (TEAEs) during the 56-week treatment phase [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	August 2010
Study Completion Date:	October 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lacosamide	Drug: Lacosamide Lacosamide is supplied as 50 mg and 100 mg tablets. The starting lacosamide dose will be the same dose reached by a subject at the end of SP0961. At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100mg/day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/day per week up to a maximum of 800 mg/day. Lacosamide will be administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase is followed by a 5-week End-of-Study Phase, lasting up to 5 weeks, during which subjects will be tapered off lacosamide at a recommended decrease rate of 200 mg/day per week. Other Name: Vimpat®

Arms

Assigned Interventions

Experimental: Lacosamide

Drug: Lacosamide

Lacosamide is supplied as 50 mg and 100 mg tablets. The starting lacosamide dose will be the same dose reached by a subject at the end of SP0961. At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100mg/day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/day per week up to a maximum of 800 mg/day. Lacosamide will be administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase is followed by a 5-week End-of-Study Phase, lasting up to 5 weeks, during which subjects will be tapered off lacosamide at a recommended decrease rate of 200 mg/day per week.

Other Name: Vimpat®

Eligibility

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject completed the SP0961 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 or is experiencing an ongoing serious adverse event (SAE)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118962

Show 19 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT01118962 History of Changes
Other Study ID Numbers:	SP0962
Study First Received:	May 5, 2010
Last Updated:	October 26, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Primary Generalized Tonic-Clonic (PGTC) Seizures
Absence Seizures
Myoclonic Seizures
Idiopathic Generalized Epilepsy (IGE)

Additional relevant MeSH terms:

Epilepsy
Epilepsy, Generalized
Seizures
Myoclonus
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesias

ClinicalTrials.gov processed this record on May 23, 2013

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