EpilepsyPhase 3NCT00515619

Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

A Phase 3 study testing Lacosamide in people with Epilepsy, run by UCB Pharma at 54 sites in 13 countries.

Completed

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

Trial summary

The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy. Read more about this study

Who is it for?: Ages 16 to 70 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: 376 participants
Where: 54 sitesin 13 countries
Study dates: Dec 2004to Aug 2010
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

diagnosis of Epilepsy
completion of double blind trial

Who cannot join

taking other investigational drug than Lacosamide
meeting withdrawal criteria from double blind trial

Trial locations and contacts

54 sites in 13 countries.

Country

City, postcode or hospital

54 sites in 13 countries

Australia7 sites

Study site
Adelaide
Study site
Clayton, Victoria
Study site
Maroochydore, Queensland
Study site
Parkville, Victoria
Study site
Randwick, New South Wales
Study site
West Heidelberg, Victoria
Study site
Woodville, South Australia

Other trials in Australia

Czechia6 sites

Study site
Brno
Study site
Hradec Králové
Study site
Olomouc
Study site
Ostrava-Trebovice
Study site
Pilsen
Study site
Prague

Other trials in Czechia

Germany6 sites

Study site
Berlin
Study site
Erlangen
Study site
Göttingen
Study site
Marburg, 35039
Study site
München
Study site
Ulm

Other trials in Germany

United Kingdom6 sites

Study site
Cardiff
Study site
Dundee
Study site
Glasgow
Study site
London
Study site
Salford
Study site
Swansea

Other trials in United Kingdom

France5 sites

Study site
Lille
Study site
Lyon
Study site
Montpellier
Study site
Paris
Study site
Toulouse

Other trials in France

Finland4 sites

Study site
Helsinki
Study site
Kuopio
Study site
Oulu
Study site
Tampere

Other trials in Finland

Hungary4 sites

Study site
Budapest
Study site
Pécs
Study site
Szeged
Study site
Szombathely

Other trials in Hungary

Poland4 sites

Study site
Bialystok
Study site
Gdansk
Study site
Krakow
Study site
Warsaw

Other trials in Poland

Spain4 sites

Study site
Girona
Study site
Granada
Study site
Madrid
Study site
Zaragoza

Other trials in Spain

Sweden3 sites

Study site
Gothenburg
Study site
Linköping
Study site
Stockholm

Other trials in Sweden

Lithuania2 sites

Study site
Kaunas
Study site
Vilnius

Other trials in Lithuania

Russia2 sites

Study site
Moscow
Study site
Saint Petersburg

Other trials in Russia

Croatia1 site

Study site
Zagreb

Other trials in Croatia

About this study

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

The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.

Conditions: Epilepsy
Being tested: Lacosamide
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 SPM 927, LCM
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial

Study groups in NCT00515619
Study group	Role	What they receive
Lacosamide	Experimental	50 mg and 100 mg tablets up to 800 mg/day as twice 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 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 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 5.5 years)
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 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 5.5 years)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 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 5.5 years)

Secondary outcomes (2)

Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 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, Treatment Period (up to 5.5 years)
Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 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 5.5 years)

Timeline

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

Dec 2004Aug 2010

First posted14 Aug 2007 (estimated)
Study startDec 2004
Primary completionAug 2010
Study completionAug 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 (2)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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 376 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00515619
Sponsor's protocol ID: SP0774
Other IDs: 2004-000152-16, 2004
Status last verified: Jul 2017
First submitted: 13 Aug 2007
Last updated: 28 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Borghs S, de la Loge C, Brabant Y, Cramer J. Sensitivity testing of the Seizure Severity Questionnaire (SSQ). Epilepsy Behav. 2014 Feb;31:281-5. doi: 10.1016/j.yebeh.2013.10.010. Epub 2013 Nov 22.
PubMed 24275520
Rosenow F, Kelemen A, Ben-Menachem E, McShea C, Isojarvi J, Doty P; SP774 study investigators. Long-term adjunctive lacosamide treatment in patients with partial-onset seizures. Acta Neurol Scand. 2016 Feb;133(2):136-144. doi: 10.1111/ane.12451. Epub 2015 Jul 2.
PubMed 26133811

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

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures
ClinicalTrials.gov ID: NCT00515619
Acronym / sponsor ID: SP0774
Conditions: Epilepsy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 376 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Dec 2004
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 14 Aug 2007 (estimated)
Results: Posted 9 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 main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.

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: Lacosamide50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing

Who may qualify

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

Key inclusion criteria (2 listed)

diagnosis of Epilepsy
completion of double blind trial

Key exclusion criteria (2 listed)

taking other investigational drug than Lacosamide
meeting withdrawal criteria from double blind trial

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: SPM 927, LCM50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial	Drug	Lacosamide

Primary outcome

Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
Time frame: During the Treatment Period (up to 5.5 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 5.5 Years)
Time frame: During the Treatment Period (up to 5.5 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 5.5 Years)
Time frame: During the Treatment Period (up to 5.5 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 5.5 Years)
Time frame: Baseline, Treatment Period (up to 5.5 years)
Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)
Time frame: Treatment Period (up to 5.5 years)

Results and safety

Results posted to the registry on 9 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	376	160

Primary outcome: Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)

Time frame: During the Treatment Period (up to 5.5 years). Number. Unit: Subjects

Measure	Lacosamide n = 376
Value	311

Population analysed: Of the 376 subjects who entered the study, 376 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 5.5 Years)

Time frame: During the Treatment Period (up to 5.5 years). Number. Unit: Subjects

Measure	Lacosamide n = 376
Value	33

Population analysed: Of the 376 subjects who entered the study, 376 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 5.5 Years)

Time frame: During the Treatment Period (up to 5.5 years). Number. Unit: Subjects

Measure	Lacosamide n = 376
Value	87

Population analysed: Of the 376 subjects who entered the study, 376 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 5.5 years of the study for all 376 patients. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lacosamide	87 of 376 (23.1%)	232 of 376 (61.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24275520Borghs S, de la Loge C, Brabant Y, Cramer J. Sensitivity testing of the Seizure Severity Questionnaire (SSQ). Epilepsy Behav. 2014 Feb;31:281-5. doi: 10.1016/j.yebeh.2013.10.010. Epub 2013 Nov 22.
Derived from this study: PubMed 26133811Rosenow F, Kelemen A, Ben-Menachem E, McShea C, Isojarvi J, Doty P; SP774 study investigators. Long-term adjunctive lacosamide treatment in patients with partial-onset seizures. Acta Neurol Scand. 2016 Feb;133(2):136-144. doi: 10.1111/ane.12451. Epub 2015 Jul 2.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

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

54 sites in 13 countries: 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 Epilepsy, run by UCB Pharma at 54 sites in 13 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 2 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 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Australia, Czechia, Germany, United Kingdom, France and 8 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 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 9 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 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years) (time frame: During the Treatment Period (up to 5.5 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 NCT00515619, which also lists 2 linked publications.

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 28 Aug 2017.