eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam (VERVE)
|ClinicalTrials.gov Identifier: NCT01484977|
Recruitment Status : Completed
First Posted : December 5, 2011
Results First Posted : November 26, 2014
Last Update Posted : August 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Lacosamide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Single Arm, Study Evaluating Tolerability and Efficacy of Lacosamide When Added to Levetiracetam With Withdrawal of Concomitant Sodium Channel Blocking Antiepileptic Drug in Subjects With Uncontrolled Partial-onset Seizures|
|Study Start Date :||December 2011|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED)
50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks.
- Retention at the End of the 21-week Treatment Period [ Time Frame: Duration of the Treatment Period (21 Weeks) ]Retention is a summary measure that integrates both the patient's and clinician's assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484977
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|Study Director:||UCB Clinical Trial Call Center||877-822-9493|