Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures

Completed · Phase 3

Conditions studied: Epilepsy

In brief

The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Key facts

Study ID

NCT00520741

Run by

UCB BIOSCIENCES, Inc.

People needed

426

Starts

2007-08-01

Expected to finish

2012-12-01

Last updated by the study team

2018-07-19

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and or Complex Partial Seizures (with or without secondary generalization)
• Must be experiencing 2 to 40 seizures per 28-day period
• Stable dose of 1 or 2 marketed antiepileptic drugs
• Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA product label at screening

You may not qualify if…

• Subject has a history of primary generalized or unclassified seizures
• Seizure disorder primarily characterized by isolated auras
• History of status epilepticus
• Seizures that are uncountable due to clustering
• Has greater than 5 seizures/day
• Subjects taking Benzodiazepines, Phenobarbital or Primidone
• Subject has Vagus Nerve Stimulation (VNS)
• Significant medical or psychiatric condition
• History of alcohol or drug abuse
• History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997

Where it is running

• 10 — Birmingham, Alabama, United States
• 18 — Huntsville, Alabama, United States
• 42 — Northport, Alabama, United States
• 14 — Phoenix, Arizona, United States
• 151 — Phoenix, Arizona, United States
• 9 — Phoenix, Arizona, United States
• 150 — Sun City, Arizona, United States
• 103 — Tucson, Arizona, United States
• 102 — Jonesboro, Arkansas, United States
• 7 — Little Rock, Arkansas, United States
• 86 — Little Rock, Arkansas, United States
• 120 — La Habra, California, United States
• 156 — Loma Linda, California, United States
• 59 — Los Angeles, California, United States
• 76 — Los Angeles, California, United States
• 45 — Newport Beach, California, United States
• 21 — Santa Monica, California, United States
• 107 — Torrance, California, United States
• 60 — Aurora, Colorado, United States
• 25 — Fairfield, Connecticut, United States
• 133 — Dover, Delaware, United States
• 37 — Washington D.C., District of Columbia, United States
• 94 — Doral, Florida, United States
• 108 — Gainesville, Florida, United States
• 48 — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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