Add on Lacosamide Versus High Dose Monotherapy

NCT01345058 | Completed Phase 3 Results DMC

• 1 other identifier: 2010-P-001630
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

Keywords

Epilepsy; antiepileptic drug; polytherapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Six Month Seizure Freedom

  Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.

  6 Months

Secondary Outcomes (4)

• Number of Seizure-Free Days

  6 Months

• Time to First Seizure After Therapeutic Dose is Reached

  6 Months

• Retention Rate

  6 Months

• Number of Participants With Treatment-Emergent Adverse Events (TEAE)

  6 Months

Study Arms (2)

Lacosamide + Low-Dose Levetiracetam

EXPERIMENTAL

Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.

Drug: lacosamide; Drug: levetiracetam

Control Group (High-Dose Levetiracetam)

OTHER

Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.

Drug: levetiracetam

Interventions

lacosamide DRUG

Lacosamide maximum of 200 mg/day, to be titrated as follows: * Week 1: 50 mg twice a day * Beginning Week 2: 100 mg twice a day.

Also known as: Vimpat

Lacosamide + Low-Dose Levetiracetam

levetiracetam DRUG

Low dose ≤1500 mg/day, High dose \>1500 mg/day

Control Group (High-Dose Levetiracetam); Lacosamide + Low-Dose Levetiracetam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 or older
• 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
• Monotherapy on levetiracetam less than or equal to 1500 mg/day for at least two weeks
• Breakthrough seizure while on stable dose (\>5 days) of levetiracetam monotherapy regimen, not due to provocative factors (e.g. hypoglycemia, head trauma, missed medications)

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Lee JW, Alam J, Llewellyn N, Hurwitz S, Bubrick EB, Sarkis RA, Weisholtz D, Yu H, Putta S, Dworetzky BA, Pennell PB. Open Label Trial of Add on Lacosamide Versus High Dose Levetiracetam Monotherapy in Patients With Breakthrough Seizures. Clin Neuropharmacol. 2016 May-Jun;39(3):128-31. doi: 10.1097/WNF.0000000000000144.

  PMID: 26992155 RESULT

MeSH Terms

Conditions

Epilepsy

Interventions

Lacosamide; Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jong Woo Lee, MD, PhD
• Organization: Brigham and Women's Hospital

JLEE38@BWH.HARVARD.EDU

Study Officials

• Jong Woo Lee, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Neurologist

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: April 29, 2011
• Study Start: August 1, 2011
• Primary Completion: February 15, 2014
• Study Completion: October 21, 2014
• Last Updated: April 14, 2026
• Results First Posted: April 25, 2017

Record last verified: 2026-03

Locations

US (1)