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SP0982: A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications (VALOR)

Clinical Trial Details

Full title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy And Safety Of Lacosamide As Adjunctive Therapy For Uncontrolled Primary Generalized Tonic-Clonic Seizures In Subjects With Idiopathic Generalized Epilepsy (Sp0982)

SP0982 is a double-blind, randomized, placebo-controlled, parallel-group, multicenter study designed to assess the efficacy and safety of oral lacosamide (LCM) (VIMPATĀ®; SPM 927; previously referred to as harkoseride; (R)-2-acetamido-N-benzyl-3-methoxypropionamide, ADD 234037) twice daily [bid]) vs placebo as adjunctive therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects over 4 years of age with idiopathic generalized epilepsy (IGE) currently taking 1 to 3 concomitant antiepileptic drugs (AEDs) independent of the number of prior failed AEDs. Approximately 200 subjects across approximately 150 sites in the US, Canada, Europe, Asia, and Australia, with possible extension to other countries and regions, are planned to be randomized in this study.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Blagovest Nikolov
bln2001@med.cornell.edu

Primary Investigator(s)

Status

Open to Enrollment

Age Group

Adult

Disease