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Trial record 1 of 1 for:    NCT00655486
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Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures

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ClinicalTrials.gov Identifier: NCT00655486
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : July 15, 2011
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Brief Summary:
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 or disease Intervention/treatment Phase
Partial Epilepsies Partial Onset Seizures Drug: lacosamide Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Extension Trial to Assess the Long-term Safety and Tolerability of Lacosamide as Adjunctive Therapy in Subjects With Partial-onset Seizures
Study Start Date : April 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) [ Time Frame: 2 years ]
    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).

  2. Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years) [ Time Frame: 2 years ]
    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).



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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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): NCT00655486


Locations
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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 BIOSCIENCES, Inc.
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Additional Information:
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Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT00655486    
Other Study ID Numbers: SP0926
2014-004384-21 ( EudraCT Number )
First Posted: April 10, 2008    Key Record Dates
Results First Posted: July 15, 2011
Last Update Posted: July 17, 2018
Last Verified: July 2017
Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
Epilepsy
seizures
antiepileptic
Lacosamide
Vimpat
safety
adjunctive
Additional relevant MeSH terms:
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Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action