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Epilepsy combo therapy shows promise in small trial

NCT ID NCT01345058

Disease control Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding lacosamide (Vimpat) to a low dose of levetiracetam works better than a high dose of levetiracetam alone for controlling seizures. Fifty-six adults with epilepsy who had seizures on low-dose levetiracetam took part. The main goal was to see how many people stayed seizure-free for six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lacosamide (Vimpat) and levetiracetam
What this could lead to
If successful, this could offer a more effective way to control seizures for people whose current medication isn't working well enough.
What could go wrong
This is a small, completed Phase 3 trial with only 56 participants, so results may not apply to everyone. Adding another drug also increases the risk of side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

56 people

The number who actually took part.

Started

Aug 2011

Finished

Oct 2014

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsy

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.