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Add on Lacosamide Versus High Dose Monotherapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
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
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 ]

Secondary Outcome Measures:
  • Number of seizure-free months [ Time Frame: 6 months ]
  • Time to seizure after therapeutic dose is reached [ Time Frame: 6 months ]
  • Retention rate [ Time Frame: 6 months ]
  • Number of reported side effects [ Time Frame: 6 months ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs processed this record on February 27, 2017