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Add on Lacosamide Versus High Dose Monotherapy

This study has been completed.
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: April 25, 2017
Last verified: April 2017
  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 Drug: levetiracetam Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jong Woo Lee, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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:
  • Number of Seizure-Free Days [ Time Frame: 6 Months ]
  • 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.

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

  • 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.


Enrollment: 56
Actual Study Start Date: August 1, 2011
Study Completion Date: October 21, 2014
Primary Completion Date: February 15, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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)
  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

Publications:
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
Results First Received: March 15, 2017
Last Updated: April 25, 2017

Keywords provided by Jong Woo Lee, Brigham and Women's Hospital:
Epilepsy
antiepileptic drug
polytherapy

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

ClinicalTrials.gov processed this record on August 17, 2017