Add on Lacosamide Versus High Dose Monotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jong Woo Lee, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01345058
First received: April 28, 2011
Last updated: July 20, 2014
Last verified: July 2014
  Purpose

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
Epilepsy
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345058

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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
ClinicalTrials.gov 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:
Epilepsy
antiepileptic drug
polytherapy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014