Add on Lacosamide Versus High Dose Monotherapy

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Jong Woo Lee, Brigham and Women's Hospital Identifier:
First received: April 28, 2011
Last updated: July 20, 2014
Last verified: July 2014
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.

Condition Intervention Phase
Drug: lacosamide, levetiracetam
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Percentage of patients achieving six month seizure freedom [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of seizure-free months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time to seizure after therapeutic dose is reached [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Retention rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of reported side effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lacosamide add-on
Lacosamide will be added to low dose levetiracetam
Drug: lacosamide, levetiracetam

Lacosamide will be added to levetiracetam: minimum of 200mg/day, to be titrated as follows:

  • Week 1: 50mg twice a day
  • Week 2: 100mg twice a day.
Other Name: Vimpat
No Intervention: High dose levetiracetam
Historical controls will be used as the comparator.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 1500mg/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 AED polytherapy
  5. Presence of a vagus nerve stimulator
  6. Creatinine clearance of less than 50mL/min
  7. Blood pressure instability: pulse<50 or >100, SBP<50 or >180, clinically significant EKG abnormality
  8. History of significant drug rash or anaphylactic reaction with antiepileptic drug
  9. Patients with progressive lesions (e.g. brain tumors)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01345058

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Jong Woo Lee, MD, PhD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Jong Woo Lee, Associate Neurologist, Brigham and Women's Hospital Identifier: NCT01345058     History of Changes
Other Study ID Numbers: 2010-P-001630 
Study First Received: April 28, 2011
Last Updated: July 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
antiepileptic drug

Additional relevant MeSH terms:
Central Nervous System Agents
Nootropic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 04, 2016