Focal Epilepsy With and Without Secondary GeneralizationVICTOSNCT01673282
Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy
An observational study of Focal Epilepsy With and Without Secondary Generalization, run by UCB Pharma GmbH at 42 sites in 2 countries.
Trial summary
This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in clinical practice and will also evaluate the subsequent change in the drug load of patients after addition of VIMPAT® to their treatment regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Epilepsy With and Without Secondary Generalization
- What is being tested?
- Lacosamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 315 participants
- Where
- 42 sitesin 2 countries
- Study dates
- Jul 2012to Jul 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with focal epilepsy with or without secondary generalization.
Who may be able to join
- The patient has not received Vimpat® more than 7 days prior to start of Non-Interventional Study (NIS)
- The patient must have a diagnosis of epilepsy with partial-onset seizures with or without secondary generalization
- Based on the physician's clinical judgment, it is in the patient's best interest to be prescribed adjunctive Vimpat® (ie, the decision to prescribe Vimpat® is made by the physician)
- Patient must be at least 18 years of age
- The patient must have had at least one seizure within the last 3 months prior to enrolment
Who cannot join
None listed.
Trial locations and contacts
42 sites in 2 countries.
42 sites in 2 countries
Germany39 sites
18
Berlin
34
Berlin
43
Berlin
66
Berlin
23
Bonn
28
Cologne
40
Cologne
25
Dortmund
35
Düsseldorf
48
Erbach im Odenwald
59
Erlangen
30
Essen
47
Giessen
29
Göttingen
37
Göttingen
05
Haag
12
Halle
19
Halle
39
Heidenheim
54
Ibbenbueren
27
Jena
04
Jülich
13
Kehl-Kork
36
Kiel
38
Leipzig
52
Magdeburg
67
Mainz
49
Mittweida
01
München
08
Oranienburg
17
Osnabrück
14
Radeberg
15
Rüsselsheim am Main
16
Senftenberg
41
Stuttgart
09
Troisdorf
22
Tübingen
20
Ulm
07
Westerstede
About this study
Official title: A Non-interventional, Observational Study Evaluating Changes in Drug Load and Seizure Frequency Using Vimpat (Lacosamide) in Daily Clinical Practice in Combination Therapy With Sodium Channel Blocking Anti-epileptic Drugs (AEDs) or Non Sodium Channel Blocking AEDs
This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in clinical practice and will also evaluate the subsequent change in the drug load of patients after addition of VIMPAT® to their treatment regimen.
- Being tested
- Lacosamide
- Keywords
- Lacosamide, Vimpat, Focal Epilepsy, Drug Load, AED, SP1065
- 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, LCM
Route of Administration: oral/subcutaneous Form and Dosage: Tablet (50 mg/100 mg/150 mg, 200 mg); Syrup (10 mg/ml); Solution for infusion (10 mg/ml).
| Study group | Role | What they receive |
|---|---|---|
| Vimpat + Na Channel Blocking AED | Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED. Receives: Drug: Lacosamide | |
| Vimpat + Non-Na Channel Blocking AED | Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED. Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)
Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.
Measured: From Baseline (Day 0) to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2015
- Study completionJul 2015
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 Focal Epilepsy With and Without Secondary GeneralizationStudies 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
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673282
- Sponsor's protocol ID
- SP1065
- Acronym
- VICTOS
- Status last verified
- Sep 2016
- First submitted
- 22 Aug 2012
- Last updated
- 15 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Observational Study Evaluating Changes in Drug Load and Seizure Frequency Using Vimpat (Lacosamide) in Daily Clinical Practice in Combination Therapy With Sodium Channel Blocking Anti-epileptic Drugs (AEDs) or Non Sodium Channel Blocking AEDs
- ClinicalTrials.gov ID
- NCT01673282
- Acronym / sponsor ID
- VICTOS / SP1065
- Keywords
- Lacosamide, Vimpat, Focal Epilepsy, Drug Load, AED, SP1065
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- UCB Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Posted 15 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in clinical practice and will also evaluate the subsequent change in the drug load of patients after addition of VIMPAT® to their treatment regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vimpat + Na Channel Blocking AED | – | Drug: LacosamidePatients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED. |
| Vimpat + Non-Na Channel Blocking AED | – | Drug: LacosamidePatients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with focal epilepsy with or without secondary generalization.
Key inclusion criteria (5 listed)
- The patient has not received Vimpat® more than 7 days prior to start of Non-Interventional Study (NIS)
- The patient must have a diagnosis of epilepsy with partial-onset seizures with or without secondary generalization
- Based on the physician's clinical judgment, it is in the patient's best interest to be prescribed adjunctive Vimpat® (ie, the decision to prescribe Vimpat® is made by the physician)
- Patient must be at least 18 years of age
- The patient must have had at least one seizure within the last 3 months prior to enrolment
Key exclusion criteria (0 listed)
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, LCMRoute of Administration: oral/subcutaneous Form and Dosage: Tablet (50 mg/100 mg/150 mg, 200 mg); Syrup (10 mg/ml); Solution for infusion (10 mg/ml). | Drug | Vimpat + Na Channel Blocking AED, Vimpat + Non-Na Channel Blocking AED |
Primary outcome
The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)
Time frame: From Baseline (Day 0) to 6 months
Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
UCB Pharma
42 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Epilepsy With and Without Secondary Generalization, run by UCB Pharma GmbH at 42 sites in 2 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 5 inclusion and 0 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 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Germany, Austria. 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 15 Nov 2016). 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 Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months) (time frame: From Baseline (Day 0) to 6 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 15 Nov 2016.