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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 Phase 3 (EP0012)

Clinical Trial Details

Epilepsy is the second most common disorder affecting the nervous system and more than 40 million people suffer from epilepsy world-wide. You are being invited to participate in this research study because you have been diagnosed with generalized epilepsy with uncontrolled primary generalized tonic-clonic (PGTC) seizures [sometimes also referred to as Grand-Mal seizures]. You are eligible for this study if the seizures that you experience are not considered to be well controlled by you and your doctor.

The purpose of this study is to assess the long term safety and helpfulness of Lacosamide (LCM) therapy in subjects with your epilepsy diagnosis. This study provides continued access to Lacosamide (LCM) for subjects rolling over from study SP0982.

Lacosamide is an investigational drug that has not been approved for use in PGTC seizures. Lacosamide has been approved by the United States Food and Drug Administration (FDA) as monotherapy or adjunctive therapy of partial onset seizures, and by the European Medicines Agencies (EMA) as adjunctive treatment for partial onset seizures. Approximately 6,651 subjects have been exposed to lacosamide in clinical studies. Since the initial launch of lacosamide tablets and injection in May 2009, there have been more than 200,000 patient exposures in the U.S., as of 2014. This includes healthy subjects and subjects with partial-onset seizures, diabetic neuropathic pain, mixed neuropathic pain, post-herpetic neuralgia, fibromyalgia, osteoarthritis, and migraine. However, use of lacosamide for treatment of primary generalized tonic-clonic (PGTC) seizures has not been approved by the EMA, U.S. FDA or by regulatory authorities in other countries.

Key Eligibility: 
  • Diagnosis of ¬†generalized epilepsy with uncontrolled primary generalized tonic-clonic (PGTC) seizures [sometimes also referred to as Grand-Mal seizures]
  • Detailed criteria to be reviewed with study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Blagovest Nikolov
bln2001@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1505016206

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease