EpilepsyPhase 3NCT01345058
Add on Lacosamide Versus High Dose Monotherapy
A Phase 3 study testing lacosamide and levetiracetam in people with Epilepsy, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- lacosamide and levetiracetam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2011to 21 Oct 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder
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.
- Conditions
- Epilepsy
- Being tested
- lacosamide, levetiracetam
- Keywords
- Epilepsy, antiepileptic drug, polytherapy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lacosamideDrug
Also called Vimpat
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.
levetiracetamDrug
Low dose ≤1500 mg/day, High dose >1500 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide + Low-Dose Levetiracetam | Experimental | 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. Receives: Drug: lacosamide; Drug: levetiracetam |
| Control Group (High-Dose Levetiracetam) | Other | 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. Receives: Drug: levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (4)
Number of Seizure-Free Days
Measured: 6 Months
Time to First Seizure After Therapeutic Dose is Reached
Time in days until the first seizure after the therapeutic dose is reached occurs.
Measured: 6 Months
Retention Rate
Retention rate is defined as the percentage of participants who remained on the study drug after study completion.
Measured: 6 Months
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study start1 Aug 2011
- Primary completion15 Feb 2014
- Study completion21 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Woo Lee, Brigham and Women's Hospital
- Investigators
- Jong Woo Lee, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345058
- Sponsor's protocol ID
- 2010-P-001630
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2011
- Last updated
- 14 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26992155
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder
- ClinicalTrials.gov ID
- NCT01345058
- Acronym / sponsor ID
- 2010-P-001630
- Conditions
- Epilepsy
- Keywords
- Epilepsy, antiepileptic drug, polytherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 15 Feb 2014 (actual)
- Study completion
- 21 Oct 2014 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lacosamide + Low-Dose Levetiracetam | Experimental | Drug: lacosamide, Drug: levetiracetamParticipants 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. |
| Control Group (High-Dose Levetiracetam) | Other | Drug: levetiracetamHistorical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lacosamideAlso: VimpatLacosamide 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. | Drug | Lacosamide + Low-Dose Levetiracetam |
| levetiracetamLow dose ≤1500 mg/day, High dose >1500 mg/day | Drug | Control Group (High-Dose Levetiracetam), Lacosamide + Low-Dose Levetiracetam |
Primary outcome
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.
4 secondary outcomes
Number of Seizure-Free Days
Time frame: 6 Months
Time to First Seizure After Therapeutic Dose is Reached
Time frame: 6 Months
Retention Rate
Time frame: 6 Months
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26992155Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Woo Lee, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lacosamide and levetiracetam in people with Epilepsy, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Six Month Seizure Freedom (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01345058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.