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NCT Number: NCT01345058

Add on Lacosamide Versus High Dose Monotherapy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

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.

Other names: Vimpat

Levetiracetam

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2011
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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