Partial EpilepsiesPhase 3NCT00522275

Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

A Phase 3 study testing lacosamide in people with Partial Epilepsies, run by UCB BIOSCIENCES, Inc. at 60 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy Read more about this study

Who is it for?: Ages 16 to 70 years
Conditions the study is for: Partial Epilepsies
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: 308 participants
Where: 60 sitesUnited States
Study dates: Oct 2004to Oct 2009
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 16 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Completion of parent clinical trial for treatment of partial seizures

Who cannot join

Receiving any study drug or experimental device other than lacosamide
Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event

Trial locations and contacts

60 sites in 1 country.

City, postcode or hospital

60 sites in 1 country

United States60 sites

Study site
Albuquerque, New Mexico
Study site
Asheville, North Carolina
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Atlanta, Georgia
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Baltimore, Maryland
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Beaufort, South Carolina
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Bethesda, Maryland
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Birmingham, Alabama
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Boston, Massachusetts
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Bradenton, Florida
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Buffalo, New York
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Charleston, South Carolina
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Charlottesville, Virginia
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Chesterfield, Missouri
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Chicago, Illinois
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Cincinnati, Ohio
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Cleveland, Ohio
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Columbus, Ohio
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Dallas, Texas
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Durham, North Carolina
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Englewood, Colorado
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Fairfield, Connecticut
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Golden Valley, Minnesota
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Greenville, North Carolina
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Hershey, Pennsylvania
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Indianapolis, Indiana
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Jacksonville, Florida
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Lexington, Kentucky
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Little Rock, Arkansas
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Los Angeles, California
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Louisville, Kentucky
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Maitland, Florida
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Marshfield, Wisconsin
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Medford, Oregon
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Milwaukee, Wisconsin
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Mobile, Alabama
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Morgantown, West Virginia
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Nashville, Tennessee
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New York, New York
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Newport News, Virginia
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Norfolk, Virginia
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Providence, Rhode Island
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Richmond, Virginia
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Rochester, New York
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Saint Cloud, Minnesota
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Saint Paul, Minnesota
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San Antonio, Texas
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San Francisco, California
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Seattle, Washington
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Somerset, New Jersey
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Springfield, Illinois
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St. Petersburg, Florida
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Syracuse, New York
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Tallahassee, Florida
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Tampa, Florida
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Toledo, Ohio
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Tulsa, Oklahoma
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Wichita, Kansas
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Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy

Conditions: Partial Epilepsies
Being tested: lacosamide
Keywords: Adjunctive treatment in epilepsy, add-on treatment for epilepsy, partial seizures, AEDs, antiepileptic drugs, seizures
Medical subject headings: Epilepsies, Partial, Seizures

What participants receive

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

lacosamideDrug
50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial

Study groups in NCT00522275
Study group	Role	What they receive
Lacosamide	Experimental	Up to 800 mg/day lacosamide (flexible dosing) Receives: Drug: lacosamide

What is being measured

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

Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Measured: During the Treatment Period (Maximum 6 years)
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Measured: During the Treatment Period (Maximum 6 years)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)
Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Measured: During the Treatment Period (Maximum 6 years)

Secondary outcomes (2)

Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)
Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Measured: Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)
Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)
At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.
Measured: Treatment Period (Maximum 6 years)

Timeline

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

Oct 2004Oct 2009

First posted29 Aug 2007 (estimated)
Study startOct 2004
Primary completionOct 2009
Study completionOct 2009

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 Partial EpilepsiesStudies 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 308 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00522275
Sponsor's protocol ID: SP0756
Other IDs: 2014-004398-18, 2014
Status last verified: Jul 2017
First submitted: 27 Aug 2007
Last updated: 18 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Expanded access: Available

Publications

Husain A, Chung S, Faught E, Isojarvi J, McShea C, Doty P. Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia. 2012 Mar;53(3):521-8. doi: 10.1111/j.1528-1167.2012.03407.x.
PubMed 22372628

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

RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Enrolling by invitationPhase 3
An Open-label Study of XEN1101 in Epilepsy
Focal Epilepsy, Tonic-Clonic Seizures

All Partial Epilepsies trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures
ClinicalTrials.gov ID: NCT00522275
Acronym / sponsor ID: SP0756
Conditions: Partial Epilepsies
Keywords: Adjunctive treatment in epilepsy, add-on treatment for epilepsy, partial seizures, AEDs, antiepileptic drugs, seizures
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 308 participants (actual)
Lead sponsor: UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2004
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 29 Aug 2007 (estimated)
Results: Posted 22 Nov 2010

Clinical summary

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

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from 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: lacosamideUp to 800 mg/day lacosamide (flexible dosing)

Who may qualify

Ages: 16 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Completion of parent clinical trial for treatment of partial seizures

Key exclusion criteria (2 listed)

Receiving any study drug or experimental device other than lacosamide
Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event

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
lacosamide50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial	Drug	Lacosamide

Primary outcome

Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Time frame: During the Treatment Period (Maximum 6 years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Time frame: During the Treatment Period (Maximum 6 years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)
Time frame: During the Treatment Period (Maximum 6 years)
Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

2 secondary outcomes

Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)
Time frame: Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)
Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)
Time frame: Treatment Period (Maximum 6 years)

Results and safety

Results posted to the registry on 22 Nov 2010, 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	308	138

Primary outcome: Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)

Time frame: During the Treatment Period (Maximum 6 years). Number. Unit: subjects

Measure	Lacosamide n = 308
Value	288

Population analysed: Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.

Primary outcome: Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)

Time frame: During the Treatment Period (Maximum 6 years). Number. Unit: subjects

Measure	Lacosamide n = 308
Value	33

Population analysed: Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.

Primary outcome: Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)

Time frame: During the Treatment Period (Maximum 6 years). Number. Unit: subjects

Measure	Lacosamide n = 308
Value	71

Population analysed: Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Maximum of 6 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lacosamide	71 of 308 (23.1%)	265 of 308 (86%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22372628Husain A, Chung S, Faught E, Isojarvi J, McShea C, Doty P. Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia. 2012 Mar;53(3):521-8. doi: 10.1111/j.1528-1167.2012.03407.x.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Partial Epilepsies

RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Enrolling by invitationPhase 3
An Open-label Study of XEN1101 in Epilepsy
Focal Epilepsy, Tonic-Clonic Seizures

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)

60 sites 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 in people with Partial Epilepsies, run by UCB BIOSCIENCES, Inc. at 60 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 1 inclusion and 2 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 18 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 60 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 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 22 Nov 2010). 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?

Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) (time frame: During the Treatment Period (Maximum 6 years)). The study lists 3 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 NCT00522275, 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 18 Jul 2018.