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Add on Lacosamide Versus High Dose Monotherapy | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Add on Lacosamide Versus High Dose Monotherapy

Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder

NCT01345058•Brigham and Women's Hospital

Summary

This is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults age 18 or older
•2. Determined to have had at least two partial seizures by an epilepsy specialist, or to have had a single partial seizure with clinical and/or laboratory evidence of a high seizure recurrence risk
•3. Monotherapy on levetiracetam less than or equal to 1500 mg/day for at least two weeks
•4. Breakthrough seizure while on stable dose (\>5 days) of levetiracetam monotherapy regimen, not due to provocative factors (e.g. hypoglycemia, head trauma, missed medications)

Exclusion Criteria

•1. Clinical suspicion of nonepileptic psychogenic seizures or idiopathic generalized epilepsy
•2. Pregnant, child-bearing age not using contraception, or breast feeding
•3. Medical contraindication to adding lacosamide
•4. History of antiepileptic drug (AED) polytherapy
•5. Presence of a vagus nerve stimulator
•6. Creatinine clearance of less than 50 mL/min
•7. Blood pressure instability: pulse \<50 or \>100, systolic blood pressure (SBP) \<50 or \>180, clinically significant electrocardiogram (EKG) abnormality
•8. History of significant drug rash or anaphylactic reaction with antiepileptic drug
•9. Patients with progressive lesions (e.g. brain tumors)

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

August 1, 2011

Primary Completion Date

February 15, 2014

Completion Date

October 21, 2014

Last Updated

May 30, 2017

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

lacosamide

DRUG

levetiracetam

DRUG

Thalamus Seizure Detection With a Deep Brain Stimulator System

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Epilepsy; Seizure

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RECRUITINGPHASE1

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Add on Lacosamide Versus High Dose Monotherapy

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

MEHMO Natural History and Biomarkers