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Add on Lacosamide Versus High Dose Monotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01345058
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : April 25, 2017
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
Jong Woo Lee, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: lacosamide Drug: levetiracetam Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder
Actual Study Start Date : August 1, 2011
Actual Primary Completion Date : February 15, 2014
Actual Study Completion Date : October 21, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: Lacosamide + Low-Dose Levetiracetam
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

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.
Other Name: Vimpat

Drug: levetiracetam
Low dose ≤1500 mg/day, High dose >1500 mg/day

Control Group (High-Dose Levetiracetam)
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
Low dose ≤1500 mg/day, High dose >1500 mg/day

Primary Outcome Measures :
  1. Percentage of Participants Achieving Six Month Seizure Freedom [ Time Frame: 6 Months ]
    Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.

Secondary Outcome Measures :
  1. Number of Seizure-Free Days [ Time Frame: 6 Months ]
  2. Time to First Seizure After Therapeutic Dose is Reached [ Time Frame: 6 Months ]
    Time in days until the first seizure after the therapeutic dose is reached occurs.

  3. Retention Rate [ Time Frame: 6 Months ]
    Retention rate is defined as the percentage of participants who remained on the study drug after study completion.

  4. Number of Participants With Treatment-Emergent Adverse Events (TEAE) [ Time Frame: 6 Months ]
    An Adverse Event (AE) is defined as any untoward medical occurrence (side effect) in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurs after receiving the drug.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01345058

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
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Principal Investigator: Jong Woo Lee, MD, PhD Brigham and Women's Hospital
Publications of Results:
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Responsible Party: Jong Woo Lee, Associate Neurologist, Brigham and Women's Hospital Identifier: NCT01345058    
Other Study ID Numbers: 2010-P-001630
First Posted: April 29, 2011    Key Record Dates
Results First Posted: April 25, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017
Keywords provided by Jong Woo Lee, Brigham and Women's Hospital:
antiepileptic drug
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nootropic Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action