Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
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|ClinicalTrials.gov Identifier: NCT00530855|
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : June 3, 2015
Last Update Posted : July 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Lacosamide||Phase 3|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||322 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Lacosamide tablets for dosing 100 -800 mg/day
50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years
Other Name: Vimpat
- Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ]Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
- Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ]Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
- Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ]
A TEAE is defined as 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 phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.
An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).
- Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ]
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): NCT00530855
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|