Partial EpilepsiesPhase 2NCT00552305

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

A Phase 2 study testing lacosamide in people with Partial Epilepsies, run by UCB Pharma at 59 sites in 8 countries.

Completed

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

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?: Any age
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: 370 participants
Where: 59 sitesin 8 countries
Study dates: Aug 2001to Feb 2010
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 Any age
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

59 sites in 8 countries.

Country

City, postcode or hospital

59 sites in 8 countries

United States43 sites

Study site
Ann Arbor, Michigan
Study site
Baltimore, Maryland
Study site
Bennington, Vermont
Study site
Birmingham, Alabama
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Boston, Massachusetts
Study site
Charlottesville, Virginia
Study site
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
Study site
Crestview Hills, Kentucky
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Dallas, Texas
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Detroit, Michigan
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Durham, North Carolina
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Englewood, Colorado
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Frederick, Maryland
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Gainesville, Florida
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Hershey, Pennsylvania
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Hollywood, Florida
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Huntsville, Alabama
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Indianapolis, Indiana
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Iowa City, Iowa
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Irving, Texas
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Lexington, Kentucky
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Little Rock, Arkansas
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Los Angeles, California
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Lubbock, Texas
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Marshfield, Wisconsin
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Miami, Florida
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Milwaukee, Wisconsin
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Nashville, Tennessee
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New York, New York
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Ponte Vedra Beach, Florida
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Saint Paul, Minnesota
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Somerset, New Jersey
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Springfield, Illinois
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St Louis, Missouri
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Tucson, Arizona
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Wichita, Kansas
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Wichita Falls, Texas

Other trials in United States

Germany4 sites

Study site
Bonn
Study site
Erlangen
Study site
Kehl Kork
Study site
Schwalmstedt-Treysa

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United Kingdom3 sites

Study site
Bucks/London
Study site
Glasgow
Study site
Liverpool

Other trials in United Kingdom

Hungary2 sites

Study site
Budapest
Study site
Zalaegerszeg

Other trials in Hungary

Lithuania2 sites

Study site
Kaunas
Study site
Vilnius

Other trials in Lithuania

Sweden2 sites

Study site
Gothenburg
Study site
Stockholm

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Switzerland2 sites

Study site
Bern/Biel
Study site
Zurich

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Poland1 site

Study site
Poznan

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About this study

Official title: An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy 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
Medical subject headings: Epilepsies, Partial

What participants receive

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

lacosamideDrug
Also called Vimpat
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial

Study groups in NCT00552305
Study group	Role	What they receive
Lacosamide	Experimental	50mg and 100mg tablets up to 800 mg/day as twice a day (BID) 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 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 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 (up to 8 years)
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 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 (up to 8 years)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
Measured: During the Treatment Period (up to 8 years)

Secondary outcomes (2)

Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)
Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.
Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Measured: Baseline, End of Treatment Period (up to 8 years)
Percentage of at Least 50% Responders During the Treatment Period (up to 8 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. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency
Measured: Treatment Period (up to 8 years)

Timeline

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

Aug 2001Feb 2010

First posted1 Nov 2007 (estimated)
Study startAug 2001
Primary completionFeb 2010
Study completionFeb 2010

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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 370 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00552305
Sponsor's protocol ID: SP0615
Status last verified: Jul 2017
First submitted: 30 Oct 2007
Last updated: 17 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Expanded access: Available

Publications

Rosenfeld W, Fountain NB, Kaubrys G, Ben-Menachem E, McShea C, Isojarvi J, Doty P; SP615 Study Investigators. Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years. Epilepsy Behav. 2014 Dec;41:164-70. doi: 10.1016/j.yebeh.2014.09.074. Epub 2014 Oct 27.
PubMed 25461210

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 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures
ClinicalTrials.gov ID: NCT00552305
Acronym / sponsor ID: SP0615
Conditions: Partial Epilepsies
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 370 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Aug 2001
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 1 Nov 2007 (estimated)
Results: Posted 2 Sep 2011

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: lacosamide50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing

Who may qualify

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
lacosamideAlso: Vimpat50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial	Drug	Lacosamide

Primary outcome

Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
Time frame: During the Treatment Period (up to 8 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 (up to 8 Years)
Time frame: During the Treatment Period (up to 8 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 (up to 8 Years)
Time frame: During the Treatment Period (up to 8 years)
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.

2 secondary outcomes

Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)
Time frame: Baseline, End of Treatment Period (up to 8 years)
Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)
Time frame: Treatment Period (up to 8 years)

Results and safety

Results posted to the registry on 2 Sep 2011, 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	370	120

Primary outcome: Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)

Time frame: During the Treatment Period (up to 8 years). Number. Unit: subjects

Measure	Lacosamide n = 370
Value	343

Population analysed: Of the 370 subjects who entered the study, 370 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 (up to 8 Years)

Time frame: During the Treatment Period (up to 8 years). Number. Unit: subjects

Measure	Lacosamide n = 370
Value	47

Population analysed: Of the 370 subjects who entered the study, 370 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 (up to 8 Years)

Time frame: During the Treatment Period (up to 8 years). Number. Unit: subjects

Measure	Lacosamide n = 370
Value	125

Population analysed: Of the 370 subjects who entered the study, 370 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: The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lacosamide	125 of 370 (33.8%)	307 of 370 (83%)	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.
Derived from this study: PubMed 25461210Rosenfeld W, Fountain NB, Kaubrys G, Ben-Menachem E, McShea C, Isojarvi J, Doty P; SP615 Study Investigators. Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years. Epilepsy Behav. 2014 Dec;41:164-70. doi: 10.1016/j.yebeh.2014.09.074. Epub 2014 Oct 27.
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)

59 sites in 8 countries: 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 Partial Epilepsies, run by UCB Pharma at 59 sites in 8 countries.

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 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 59 sites in United States, Germany, United Kingdom, Hungary, Lithuania and 3 more countries. 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 2 Sep 2011). 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 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years) (time frame: During the Treatment Period (up to 8 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 NCT00552305, 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.