EpilepsyPhase 2NCT01118949

Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

A Phase 2 study testing Lacosamide in people with Epilepsy, run by UCB BIOSCIENCES, Inc. at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy. Read more about this study

Who is it for?: Ages 16 to 65 years
Conditions the study is for: Epilepsy
What is being tested?: Lacosamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 25 sitesUnited States
Study dates: May 2010to Aug 2011
Phase: Phase 2
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 16 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subject has a diagnosis of uncontrolled epilepsy with primary generalized tonic-clonic (PGTC) seizures and idiopathic generalized epilepsy. Diagnosis should have been established by an electroencephalogram (EEG) with generalized spike-wave discharges within 5 years of the screening visit
Subject has ≥1 PGTC seizure within the 12 weeks prior to the screening visit
Subject has a stable dose regimen of 1 to 3 marketed antiepileptic drug(s) (AEDs) with or without additional concurrent stable Vagus Nerve Stimulation (VNS). The VNS must have been in place for at least 6 months prior to study entry with constant settings for at least 28 days prior to the screening visit and during the Baseline Phase. Benzodiazepines will be counted as an AED

Who cannot join

Subject has a history of partial-onset seizures or EEG findings consistent with partial onset seizures
Subject has a history of status epilepticus within the 5-year Period prior to Visit 1
Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events
Subject has any medical or psychiatric condition
Subject has any history of alcohol or drug abuse
Subject is currently taking felbamate

Show all 9Show fewer

Subject has ever taken vigabatrin and has no visual fields examination report available or if results of the examination are abnormal
Subject is on a ketogenic diet
Subject has a known sodium channelopathy

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Study site
Alabaster, Alabama
Study site
Atlanta, Georgia
Study site
Aurora, Colorado
Study site
Bethesda, Maryland
Study site
Boise, Idaho
Study site
Charleston, South Carolina
Study site
Charlottesville, Virginia
Study site
Chesterfield, Missouri
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Fort Wayne, Indiana
Study site
Hershey, Pennsylvania
Study site
Houston, Texas
Study site
Lexington, Kentucky
Study site
Little Rock, Arkansas
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Phoenix, Arizona
Study site
Renton, Washington
Study site
Rome, Georgia
Study site
San Francisco, California
Study site
Scarborough, Maine

Other trials in United States

About this study

Official title: An Open-Label Pilot Study to Assess the Safety of Oral Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.

Conditions: Epilepsy
Being tested: Lacosamide
Keywords: Primary Generalized Tonic-Clonic (PGTC) Seizures, Absence Seizures, Myoclonic Seizures, Idiopathic Generalized Epilepsy (IGE)
Medical subject headings: Epilepsy, Seizures, Epilepsy, Idiopathic Generalized

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LacosamideDrug
Also called Vimpat®
Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.

Study groups in NCT01118949
Study group	Role	What they receive
Lacosamide	Experimental	Not described Receives: Drug: Lacosamide

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase
During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:
- Seizure type
- Seizure frequency
A negative value in change of seizure days with absence seizures shows a decrease in seizure days with absence seizures.
Measured: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase
During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:
- Seizure type
- Seizure frequency
A negative value in change of seizure days with myoclonic seizures shows a decrease in seizure days with myoclonic seizures.
Measured: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)

Secondary outcomes (4)

Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The general spike-wave discharges are calculated per interpretable hours.
Measured: From Visit 2 (Week 4) to Visit 6 (Week 8)
Changes in Count of 3 Hertz (Hz) Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The 3 Hertz (Hz) spike-wave discharges are calculated per awake hours.
Measured: From Visit 2 (Week 4) to Visit 6 (Week 8)
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Measured: From Visit 2 (Week 4) to Visit 7 (Week 13)
Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Measured: From Visit 2 (Week 4) to Visit 7 (Week 13)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Aug 2011

First posted7 May 2010 (estimated)
Study startMay 2010
Primary completionAug 2011
Study completionAug 2011

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.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01118949
Sponsor's protocol ID: SP0961
Other IDs: 2014-004379-22, 2014
Status last verified: Mar 2018
First submitted: 5 May 2010
Last updated: 17 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Expanded access: Available

Publications

Wechsler RT, Yates SL, Messenheimer J, Leroy R, Beller C, Doty P. Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension. Epilepsy Res. 2017 Feb;130:13-20. doi: 10.1016/j.eplepsyres.2016.12.015. Epub 2016 Dec 29.
PubMed 28086164

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Pilot Study to Assess the Safety of Oral Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
ClinicalTrials.gov ID: NCT01118949
Acronym / sponsor ID: SP0961
Conditions: Epilepsy
Keywords: Primary Generalized Tonic-Clonic (PGTC) Seizures, Absence Seizures, Myoclonic Seizures, Idiopathic Generalized Epilepsy (IGE)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 7 May 2010 (estimated)
Results: Posted 7 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lacosamide	Experimental	Drug: Lacosamide

Who may qualify

Ages: 16 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Subject has a diagnosis of uncontrolled epilepsy with primary generalized tonic-clonic (PGTC) seizures and idiopathic generalized epilepsy. Diagnosis should have been established by an electroencephalogram (EEG) with generalized spike-wave discharges within 5 years of the screening visit
Subject has ≥1 PGTC seizure within the 12 weeks prior to the screening visit
Subject has a stable dose regimen of 1 to 3 marketed antiepileptic drug(s) (AEDs) with or without additional concurrent stable Vagus Nerve Stimulation (VNS). The VNS must have been in place for at least 6 months prior to study entry with constant settings for at least 28 days prior to the screening visit and during the Baseline Phase. Benzodiazepines will be counted as an AED

Key exclusion criteria (9 listed)

Subject has a history of partial-onset seizures or EEG findings consistent with partial onset seizures
Subject has a history of status epilepticus within the 5-year Period prior to Visit 1
Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events
Subject has any medical or psychiatric condition
Subject has any history of alcohol or drug abuse

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: Vimpat®Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.	Drug	Lacosamide

Primary outcome

Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase
Time frame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded: * Seizure type * Seizure frequency A negative value in change of seizure days with absence seizures shows a decrease in seizure days with absence seizures.
Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase
Time frame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded: * Seizure type * Seizure frequency A negative value in change of seizure days with myoclonic seizures shows a decrease in seizure days with myoclonic seizures.

4 secondary outcomes

Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
Time frame: From Visit 2 (Week 4) to Visit 6 (Week 8)
Changes in Count of 3 Hertz (Hz) Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
Time frame: From Visit 2 (Week 4) to Visit 6 (Week 8)
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
Time frame: From Visit 2 (Week 4) to Visit 7 (Week 13)
Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
Time frame: From Visit 2 (Week 4) to Visit 7 (Week 13)

Results and safety

Results posted to the registry on 7 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lacosamide	49	40

Primary outcome: Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase

Time frame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13). Mean (Standard Deviation). Unit: number of seizure days

Measure	Lacosamide n = 44
Value	-0.37 (4.8)

Population analysed: Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects.

Primary outcome: Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase

Time frame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13). Mean (Standard Deviation). Unit: number of seizure days

Measure	Lacosamide n = 44
Value	-2.19 (5.80)

Population analysed: Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected up to 16 weeks from Baseline (Week 0 - Week 4) over the 3-weeks Titration Period (Week 4 - Week 7) and the 6-weeks Maintenance Period (Week 7 - Week 13) to the Final Clinic Visit at the end of Week 16.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lacosamide	1 of 49 (2%)	39 of 49 (79.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28086164Wechsler RT, Yates SL, Messenheimer J, Leroy R, Beller C, Doty P. Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension. Epilepsy Res. 2017 Feb;130:13-20. doi: 10.1016/j.eplepsyres.2016.12.015. Epub 2016 Dec 29.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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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.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lacosamide in people with Epilepsy, run by UCB BIOSCIENCES, Inc. at 25 sites 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 3 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 7 Sep 2012). 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?

Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase (time frame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)). The study lists 2 primary outcomes in all. 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 NCT01118949, 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 17 Jul 2018.