Epilepsies, PartialPASSNCT00771927
Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures
An observational study of Epilepsies, Partial, run by UCB Pharma at 62 sites in 5 countries.
Trial summary
SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on current therapy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsies, Partial
- What is being tested?
- Lacosamide
- How many people
- 1,005 participants
- Where
- 62 sitesin 5 countries
- Study dates
- Oct 2008to Mar 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Institutions, hospitals, primary care clinics and community based
Who may be able to join
- This study includes any subject 16 years or older who has an Epilepsy diagnosis with Partial-Onset Seizures; and whose Seizure activity is uncontrolled on current therapy
- Patients who are prescribed Vimpat or any other add-on Antiepileptic Drug (AED) may be included in the study
- The initiation of an add-on AED therapy can not be more than 2 days before the patient's start of the study
Who cannot join
- N/A
Trial locations and contacts
62 sites in 5 countries.
62 sites in 5 countries
Germany35 sites
Study site
Aschaffenburg
Study site
Bad Berka
Study site
Berlin
Study site
Bernau
Study site
Bielefeld
Study site
Bonn
Study site
Dresden
Study site
Düsseldorf
Study site
Erlangen
Study site
Essen
Study site
Freiburg im Breisgau
Study site
Göttingen
Study site
Halle
Study site
Hamburg
Study site
Jena
Study site
Kehl-Kork
Study site
Kiel
Study site
Koningstein-Falkenstein
Study site
Krefeld
Study site
Mainz
Study site
Marburg
Study site
München
Study site
Münster
Study site
Neuburg am Inn
Study site
Neukirchen-Vluyn
Study site
Oldenburg
Study site
Osnabrück
Study site
Potsdam
Study site
Radeberg, Sachsen
Study site
Ravensburg
Study site
Rotenburg (Wümme)
Study site
Stuttgart
Study site
Ulm
Study site
Vogtareuth
Study site
Westerstede
United Kingdom14 sites
Study site
Bangor
Study site
Birmingham
Study site
Cardiff
Study site
Dundee
Study site
Edinburgh
Study site
Fulwood, Preston, Lancashire
Study site
Leeds
Study site
Leicester
Study site
London
Study site
Middlesbrough
Study site
Plymouth, Devon
Study site
Salford
Study site
Sheffield
Study site
Stoke-on-Trent
France8 sites
Study site
Bron
Study site
Dijon
Study site
La Tronche
Study site
Montpellier
Study site
Nantes
Study site
Paris
Study site
Saint-Brieuc
Study site
Tain-l'Hermitage
About this study
Official title: Post-Authorization Safety Study to Evaluate the Long-Term Safety and Tolerability of Vimpat® (Lacosamide) as Add-On Therapy in Epilepsy Patients With Partial-Onset Seizures Who Are Uncontrolled on Current Therapy
SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on current therapy. Using reported adverse events, the incidence of certain cardiovascular and psychiatric events will be evaluated.
- Conditions
- Epilepsies, Partial
- Being tested
- Lacosamide
- Keywords
- Vimpat®, Lacosamide, LCM, epilepsy, epilepsies, seizure, partial seizure, partial onset, seizure disorder, single seizure, motor seizure, convulsions, add-on, AED, anti-epileptic, anti-epileptic drug, seizure control, open-label, post authorization, PASS
- Medical subject headings
- Epilepsies, Partial, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
Also called Vimpat®
Vimpat was used as per site routine practices, and in-line with the marketing authorization.
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat Receives: Drug: Lacosamide | |
| Other AED | Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study
Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation.
Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake.
Measured: From Baseline up to 12 months
Secondary outcomes (1)
The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study
Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional.
Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake.
Measured: From Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2012
- Study completionMar 2012
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.
- Other trials for Epilepsies, PartialStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771927
- Sponsor's protocol ID
- SP0942
- Acronym
- PASS
- Status last verified
- May 2013
- First submitted
- 13 Oct 2008
- Last updated
- 27 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Authorization Safety Study to Evaluate the Long-Term Safety and Tolerability of Vimpat® (Lacosamide) as Add-On Therapy in Epilepsy Patients With Partial-Onset Seizures Who Are Uncontrolled on Current Therapy
- ClinicalTrials.gov ID
- NCT00771927
- Acronym / sponsor ID
- PASS / SP0942
- Conditions
- Epilepsies, Partial
- Keywords
- Vimpat®, Lacosamide, LCM, epilepsy, epilepsies, seizure, partial seizure, partial onset
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Posted 22 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on current therapy. Using reported adverse events, the incidence of certain cardiovascular and psychiatric events will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lacosamide | – | Drug: LacosamideEpilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat |
| Other AED | – | –Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Institutions, hospitals, primary care clinics and community based
Key inclusion criteria (3 listed)
- This study includes any subject 16 years or older who has an Epilepsy diagnosis with Partial-Onset Seizures; and whose Seizure activity is uncontrolled on current therapy
- Patients who are prescribed Vimpat or any other add-on Antiepileptic Drug (AED) may be included in the study
- The initiation of an add-on AED therapy can not be more than 2 days before the patient's start of the study
Key exclusion criteria (1 listed)
- N/A
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®Vimpat was used as per site routine practices, and in-line with the marketing authorization. | Drug | Lacosamide |
Primary outcome
The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study
Time frame: From Baseline up to 12 months
Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake.
1 secondary outcome
The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study
Time frame: From Baseline up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Product informationLink provided by the sponsor.
- 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)
62 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsies, Partial, run by UCB Pharma at 62 sites in 5 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 3 inclusion and 1 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 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Germany, United Kingdom, France, Netherlands, Spain. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2013). 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?
The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study (time frame: From Baseline up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2014.