Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures

Completed · Phase 4

Conditions studied: Partial Epilepsies

In brief

To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

Key facts

Study ID

NCT00955357

Run by

UCB Pharma

People needed

461

Starts

2009-08-01

Expected to finish

2013-08-01

Last updated by the study team

2018-07-17

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Group 1:
• Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
• Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED) for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior use of rescue medication (short-term intermittent use) is acceptable
• Epilepsy diagnosis should be ≤24 months at the time of the Screening Visit
• The minimum allowed seizure frequency at any time during the 12 weeks prior to the Screening Visit is ≥3 partial-onset seizures
• Group 2:
• Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
• Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens (concurrently or sequentially)
• Epilepsy diagnosis should be ≥5 years at the time of the Screening Visit
• The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit is ≥1 partial-onset seizure per 28 days

You may not qualify if…

• Previous use of Lacosamide
• History of seizure disorder characterized primarily by isolated auras
• History of primary generalized seizures
• History of status epilepticus within last 12-months
• History of cluster seizures during the 12 week period prior to Visit 1
• Nonepileptic events, including pseudoseizures that could be confused with seizure
• Lifetime history of suicide attempt or suicidal ideation in the past 6 months
• Hypersensitivity to any component of Lacosamide
• History of drug or alcohol abuse
• History of an acute or subacutely progressive Central Nervous System (CNS) disease
• Undergone cranial surgery within the last year prior to study entry
• Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6 months
• Prior or concomitant Vigabatrin use

Where it is running

• 123 — Rancho Mirage, California, United States
• 156 — Clearwater, Florida, United States
• 157 — Destin, Florida, United States
• 140 — Hollywood, Florida, United States
• 161 — Ocala, Florida, United States
• 108 — Atlanta, Georgia, United States
• 112 — Atlanta, Georgia, United States
• 124 — Augusta, Georgia, United States
• 115 — Macon, Georgia, United States
• 118 — Rome, Georgia, United States
• 128 — Flossmoor, Illinois, United States
• 130 — Des Moines, Iowa, United States
• 102 — Bowling Green, Kentucky, United States
• 117 — Paducah, Kentucky, United States
• 107 — Houma, Louisiana, United States
• 145 — Ruston, Louisiana, United States
• 101 — Annapolis, Maryland, United States
• 162 — Waldorf, Maryland, United States
• 153 — Boston, Massachusetts, United States
• 136 — Pittsfield, Massachusetts, United States
• 144 — Springfield, Massachusetts, United States
• 151 — Kansas City, Missouri, United States
• 114 — Paterson, New Jersey, United States
• 109 — Brooklyn, New York, United States
• 103 — Irvine, California, United States

Full record on ClinicalTrials.gov

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