Trial record 2 of 2 for:    NCT00655551

Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00655486
First received: March 26, 2008
Last updated: August 30, 2011
Last verified: July 2011
  Purpose

The purpose of this study is to allow eligible subjects from the parent study, SP925 [NCT00655551] to continue lacosamide and to obtain additional long-term safety data


Condition Intervention Phase
Partial Epilepsies
Partial Onset Seizures
Drug: lacosamide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Extension Study to Assess the Long-term Safety and Tolerability of Lacosamide as Adjunctive Therapy in Subjects With Partial-onset Seizures

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).

  • Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).


Enrollment: 97
Study Start Date: April 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
Drug: lacosamide
Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).
Other Name: Vimpat

Detailed Description:

A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study [NCT00655551] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible subjects who participated in SP925 [NCT00655551] for treatment of partial-onset seizures

Exclusion Criteria:

  • Receiving any study drug or experimental device other than lacosamide.
  • Meets withdrawal criteria for parent study SP925 [NCT00655551]
  • Experiencing ongoing serious adverse event
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655486

Locations
United States, Arizona
Phoenix, Arizona, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Missouri
Chesterfield, Missouri, United States
United States, Ohio
Columbus, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
United States, Virginia
Charlottesville, Virginia, United States
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00655486     History of Changes
Other Study ID Numbers: SP926
Study First Received: March 26, 2008
Results First Received: June 15, 2011
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Epilepsy
seizures
antiepileptic
Lacosamide
Vimpat
safety
adjunctive

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014