Epilepsies, PartialVITOBANCT01098162

Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug

An observational study of Epilepsies, Partial, run by UCB Pharma GmbH at 113 sites in Germany.

Completed

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

Trial summary

The purpose of this study is to systematically and prospectively collect data from patients with partial-onset seizures in routine clinical practice setting receiving adjunctive Vimpat®. The observed population will be only patients with one baseline antiepileptic drug. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Epilepsies, Partial
How many people: 576 participants
Where: 113 sitesGermany
Study dates: Mar 2010to Jul 2013
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: Patients with Partial-Onset Seizures not sufficiently controlled with one Baseline Antiepileptic Drug (AED), treated by Epilepsy centers, clinics or office-based neurologists with adjunctive Vimpat® in routine daily practice.

Who may be able to join

The patient's treatment must be in accordance with the local marketing authorization (MA) for Vimpat®
The decision to prescribe Vimpat® has to be made by the physician before and independently of his/her decision to include the patient in the study
The Vimpat® treatment should have been started not longer than 2 weeks before study inclusion of the patient
The patient must have a diagnosis of Epilepsy with Partial-Onset Seizures
Based on the physician's clinical judgment, the patient's seizure activity is not controlled sufficiently on a current monotherapy and it is in the patient's best interest to be prescribed adjunctive Vimpat®

Who cannot join

In accordance with the Summary of Product Characteristics (SmPC)

Trial locations and contacts

113 sites in 1 country.

City, postcode or hospital

113 sites in 1 country

Germany113 sites

55
Aachen
119
Aalen
194
Aichach
191
Altenburg
136
Alzenau in Unterfranken
78
Aschaffenburg
35
Bad Berka
90
Baesweiler
107
Berlin
10A
Berlin
141
Berlin
25
Berlin
49
Berlin
66
Berlin
75
Berlin
36
Bielefeld
192
Böblingen
5
Bonn
175
Brandenburg
105
Chemnitz
176
Cologne
180
Cologne
182
Coppenbrügge
161
Dortmund
128
Dresden
21
Dresden
39
Dresden
111
Düren
38
Düsseldorf
7
Eberswalde
102
Eisenach
174
Eisenach
56
Ellwangen
50
Erbach im Odenwald
179
Erfurt
186
Erfurt
6
Erlangen
12
Essen
27
Freiburg im Breisgau
137
Fulda
112
Gelsenkirchen
103
Gera
158
Göttingen
65
Göttingen
88
Göttingen
1
Greifswald
47
Grevenbroich
134
Halle
160
Hamburg
71
Hamburg
93
Hamm
147
Heilbronn
122
Herborn
15
Herdecke
130
Höchberg
40
Immenstadt im Allgäu
52
Jena
61
Jülich
44
Karlstadt am Main
133
Kastellaun
125
Kaufbeuren
16
Kiel
99
Kleve
37
Krefeld
46
Lappersdorf
113
Leipzig
4
Leipzig
68
Leipzig
81
Leipzig
138
Lohr a. Main
148
Lüdenscheid
131
Ludwigsburg
33
Mainz
154
Mannheim
151
Mühlhausen
101
München
167
München
2
München
43
Neuburg am Inn
62
Neukirchen-Vluyn
123
Neumarkt
69
Nuremberg
80
Oelde
98
Oldenburg
87
Oranienburg
57
Potsdam
3
Radeberg
159
Rathenow
45
Ravensburg
95
Rostock
85
Rüsselsheim am Main
20
Schleswig
157
Schlüchtern
166
Schorndorf
181
Schriesheim
150
Schwäb. Gmünd
168
Schwedt
140
Senftenberg
164
Siegen
144
Sondershausen
127
Stralsund
14
Stuttgart
170
Stuttgart
104
Traunstein
183
Troisdorf
17
Tübingen
13
Ulm
48
Ulm
54
Unterhaching
171
Wermsdorf
143
Westerstede
79
Wismar
169
Wolfratshausen

Other trials in Germany

About this study

Official title: A Non-interventional Post-marketing Study, Evaluating Seizure Control and Tolerability of Vimpat® as Adjunctive Therapy to One Baseline Antiepileptic Drug in Epilepsy Patients With Partial-onset Seizures With or Without Secondary Generalization in Daily Clinical Practice in Germany

Conditions: Epilepsies, Partial
Keywords: Lacosamide, Vimpat®, Epilepsy, Partial-Onset Seizures, Adjunctive therapy
Medical subject headings: Epilepsies, Partial, Epilepsy

What participants receive

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

Study groups in NCT01098162
Study group	Role	What they receive
Vimpat®		Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.

What is being measured

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

Clinical Global Impression of Change (CGI-C) at Month 6
For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline:
- Very much improved
- Much improved
- Minimally improved
- No change
- Minimally worse
- Much worse
- Very much worse
Measured: Month 6

Secondary outcomes (5)

Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3
Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.
Change in number of partial-onset seizures was derived as follows:
Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.
Partial-onset seizures can be classified into one of the following three groups:
- Simple partial seizures
- Complex partial seizures
- Partial seizures evolving to secondarily generalized seizures.
Measured: From Baseline to Month 3
Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6
Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.
Change in number of partial-onset seizures was derived as follows:
Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.
Partial-onset seizures can be classified into one of the following three groups:
- Simple partial seizures
- Complex partial seizures
- Partial seizures evolving to secondarily generalized seizures.
Measured: From Baseline to Month 6
Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3
Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.
Change in number of partial-onset seizures with secondary generalization was derived as follows:
Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.
Partial-onset seizures with secondary generalization can be classified into one of the following three groups:
- Simple partial seizures evolving to generalized seizures
- Complex partial seizures evolving to generalized seizures
- Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures.
Measured: From Baseline to Month 3
Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6
Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.
Change in number of partial-onset seizures with secondary generalization was derived as follows:
Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.
Partial-onset seizures with secondary generalization can be classified into one of the following three groups:
- Simple partial seizures evolving to generalized seizures
- Complex partial seizures evolving to generalized seizures
- Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures.
Measured: From Baseline to Month 6
Incidence of Adverse Events During the Study
The number of subjects affected by any Treatment Emergent Adverse Event (TEAE) during the course of the study from Day 0 up to Month 6 is presented below.
Measured: From Inclusion Visit (Day 0) up to Month 6

Timeline

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

Mar 2010Jul 2013

First posted2 Apr 2010 (estimated)
Study startMar 2010
Primary completionJul 2013
Study completionJul 2013

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 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: 576 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01098162
Sponsor's protocol ID: SP0973
Acronym: VITOBA
Status last verified: Aug 2014
First submitted: 1 Apr 2010
Last updated: 3 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Runge U, Arnold S, Brandt C, Reinhardt F, Kuhn F, Isensee K, Ramirez F, Dedeken P, Lauterbach T, Noack-Rink M, Mayer T. A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: The VITOBA study. Epilepsia. 2015 Dec;56(12):1921-30. doi: 10.1111/epi.13224. Epub 2015 Nov 3.
PubMed 26526971

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

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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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RecruitingPhase 3
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A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
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All Epilepsies, Partial trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-interventional Post-marketing Study, Evaluating Seizure Control and Tolerability of Vimpat® as Adjunctive Therapy to One Baseline Antiepileptic Drug in Epilepsy Patients With Partial-onset Seizures With or Without Secondary Generalization in Daily Clinical Practice in Germany
ClinicalTrials.gov ID: NCT01098162
Acronym / sponsor ID: VITOBA / SP0973
Conditions: Epilepsies, Partial
Keywords: Lacosamide, Vimpat®, Epilepsy, Partial-Onset Seizures, Adjunctive therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 576 participants (actual)
Lead sponsor: UCB Pharma GmbHIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 2 Apr 2010 (estimated)
Results: Posted 22 Jul 2014

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Vimpat®	–	–Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with Partial-Onset Seizures not sufficiently controlled with one Baseline Antiepileptic Drug (AED), treated by Epilepsy centers, clinics or office-based neurologists with adjunctive Vimpat® in routine daily practice.

Key inclusion criteria (5 listed)

The patient's treatment must be in accordance with the local marketing authorization (MA) for Vimpat®
The decision to prescribe Vimpat® has to be made by the physician before and independently of his/her decision to include the patient in the study
The Vimpat® treatment should have been started not longer than 2 weeks before study inclusion of the patient
The patient must have a diagnosis of Epilepsy with Partial-Onset Seizures
Based on the physician's clinical judgment, the patient's seizure activity is not controlled sufficiently on a current monotherapy and it is in the patient's best interest to be prescribed adjunctive Vimpat®

Key exclusion criteria (1 listed)

In accordance with the Summary of Product Characteristics (SmPC)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Clinical Global Impression of Change (CGI-C) at Month 6
Time frame: Month 6
For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline: * Very much improved * Much improved * Minimally improved * No change * Minimally worse * Much worse * Very much worse

5 secondary outcomes

Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3
Time frame: From Baseline to Month 3
Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6
Time frame: From Baseline to Month 6
Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3
Time frame: From Baseline to Month 3
Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6
Time frame: From Baseline to Month 6
Incidence of Adverse Events During the Study
Time frame: From Inclusion Visit (Day 0) up to Month 6

Results and safety

Results posted to the registry on 22 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vimpat®	573	461

Primary outcome: Clinical Global Impression of Change (CGI-C) at Month 6

Time frame: Month 6. Number. Unit: participants

Measure	Vimpat® n = 515
Very Much Improved	160
Much Improved	179
Minimally Improved	66
No Change	72
Minimally Worse	16
Much Worse	9
Very Much Worse	2
Missing	11

Population analysed: Of the 520 subjects in the Full Analysis Set (FAS), 515 subjects are included in the analysis of this outcome measure. FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected during the whole study from Inclusion Visit (Day 0) up to Month 6.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vimpat®	56 of 571 (9.8%)	114 of 571 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26526971Runge U, Arnold S, Brandt C, Reinhardt F, Kuhn F, Isensee K, Ramirez F, Dedeken P, Lauterbach T, Noack-Rink M, Mayer T. A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: The VITOBA study. Epilepsia. 2015 Dec;56(12):1921-30. doi: 10.1111/epi.13224. Epub 2015 Nov 3.
Product InformationLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Epilepsies, Partial

RecruitingPhase 3
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RecruitingPhase 3
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Active, not recruitingPhase 2
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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)

113 sites in 1 country: 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 GmbH at 113 sites in Germany.

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 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 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in Germany. 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 Jul 2014). 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?

Clinical Global Impression of Change (CGI-C) at Month 6 (time frame: Month 6). 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 NCT01098162, 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 3 Sep 2014.