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Add on Lacosamide Versus High Dose Monotherapy

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
lacosamide
levetiracetam
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, antiepileptic drug, polytherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Lacosamide + Low-Dose Levetiracetam

Control Group (High-Dose Levetiracetam)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Six Month Seizure Freedom
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 to First Seizure After Therapeutic Dose is Reached
Time in days until the first seizure after the therapeutic dose is reached occurs.
Retention Rate
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)
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.

Full Information

First Posted
April 28, 2011
Last Updated
April 25, 2017
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01345058
Brief Title
Add on Lacosamide Versus High Dose Monotherapy
Official Title
Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2011 (Actual)
Primary Completion Date
February 15, 2014 (Actual)
Study Completion Date
October 21, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, antiepileptic drug, polytherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lacosamide + Low-Dose Levetiracetam
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (High-Dose Levetiracetam)
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
levetiracetam
Intervention Description
Low dose ≤1500 mg/day, High dose >1500 mg/day
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Six Month Seizure Freedom
Description
Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Number of Seizure-Free Days
Time Frame
6 Months
Title
Time to First Seizure After Therapeutic Dose is Reached
Description
Time in days until the first seizure after the therapeutic dose is reached occurs.
Time Frame
6 Months
Title
Retention Rate
Description
Retention rate is defined as the percentage of participants who remained on the study drug after study completion.
Time Frame
6 Months
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Description
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.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Woo Lee, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26992155
Citation
Lee JW, Alam J, Llewellyn N, Hurwitz S, Bubrick EB, Sarkis RA, Weisholtz D, Yu H, Putta S, Dworetzky BA, Pennell PB. Open Label Trial of Add on Lacosamide Versus High Dose Levetiracetam Monotherapy in Patients With Breakthrough Seizures. Clin Neuropharmacol. 2016 May-Jun;39(3):128-31. doi: 10.1097/WNF.0000000000000144.
Results Reference
result

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Add on Lacosamide Versus High Dose Monotherapy

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