• Epilepsy Trials

    Upcoming Epilepsy Clinical Trials Open to New Patients

     

    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.  

    Study Identifier: LCID:2015-041; Double-blind Lacosamide Study 

    Principal Investigator: Ritu Bagla, MD
    Sponsor: UCB, Inc. 
     

     Purpose: The purpose of this study is to assess the efficacy and safety of oral Lacosamide twice daily vs. placebo as adjunctive therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized epilepsy (IGE) currently taking 1 to 3 concomitant antiepileptic drugs (AEDs), independent of the number of prior failed AEDs. 

    Summary: The primary study objective is to demonstrate the efficacy of oral Lacosamide (LCM) versus placebo as adjunctive therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized epilepsy (IGE) currently taking 1 to 3 concomitant antiepileptic drug(s) (AEDs) independent of the number of prior failed antiepileptic drug(s) (AEDs). 

    The secondary study objective is to assess the safety and tolerability of Lacosamide (LCM) in subjects with idiopathic generalized epilepsy (IGE) with uncontrolled primary generalized tonic-clonic (PGTC) seizures. Safety variables to be assessed are adverse events (AEs); withdrawal due to adverse events (AEs); changes in hematology, chemistry, endocrinology, and urinalysis parameters; changes in 12-lead electrocardiograms (ECGs); changes in vital sign measurements; and changes in physical and neurological examination findings. The plasma concentrations of LCM will also be assessed.   

    Study Type: Investigational Drug 

    Length/Duration: The study will last a maximum of 36 weeks. 

    Contact: For more information on this study, please contact the study coordinator at Debora.G.Pimentel@lahey.org or 781-744-8383.  

     

     

    Title: An open-label, multicenter extension study to evaluate the long-term safety and efficacy of Lacosamide as adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures in subjects with idiopathic generalized epilepsy. 

     

     

     

     

    Study Identifier: LCID:2015-042; Open-label Lacosamide Study 

    Principal Investigator: Ritu Bagla, MD
    Sponsor: UCB, Inc.
     

    Purpose: This Phase 3, multicenter, open-label extension study is designed to assess the safety and tolerability of oral Lacosamide as an adjunctive therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized epilepsy (IGE) during long-term exposure. 

    Summary: The primary objective is to assess the safety and tolerability of LCM as an adjunctive therapy for uncontrolled PGTC seizures in subjects with IGE during long-term exposure. 

    The secondary objectives are to assess the efficacy of adjunctive LCM therapy during long-term exposure for the treatment of subjects with IGE experiencing uncontrolled PGTC seizures and to allow subjects who have completed SP0982 (Lahey LCID: 2015-041) and eligible Baseline failures from SP0982 (Lahey LCID: 2015-041) to receive Lacosamide. 

    Study Type: Investigational Drug 

    Length/Duration: The study will last approximately 5 years 

     Contact: For more information on this study, please contact the study coordinator at Sharmeen.Alam@lahey.org or 781-744-2958.

     

     

     

     

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