Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
|ClinicalTrials.gov Identifier: NCT00530855|
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : June 3, 2015
Last Update Posted : August 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Lacosamide||Phase 3|
|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|
|Primary Completion Date :||December 2014|
|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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530855
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|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|