Brain Tumor Related Epilepsy (BTRE)VIBESNCT02276053
Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors
An observational study of Brain Tumor Related Epilepsy (BTRE), run by UCB BIOSCIENCES GmbH at 24 sites in 6 countries.
Trial summary
This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is effective in routine clinical practice for patients with epilepsy caused by a brain tumor. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Brain Tumor Related Epilepsy (BTRE)
- How many people
- 93 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 27 Nov 2014to 4 Dec 2017
- 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 ≥ 16 years of age with brain tumor related epilepsy secondary to low grade tumor starting with lacosamide as add-on to one or two baseline anti-epileptic drugs.
Who may be able to join
- Patient has never been treated with lacosamide (LCM) prior to this non-interventional study (NIS) or treatment with LCM for the first time started no earlier than 7 days prior to enrollment in this NIS
- The decision by the treating physician to prescribe LCM falls within current standard clinical practice, and the treatment decision is clearly separated from the decision to consider inclusion of the patient in the NIS
- A Patient Data Consent form is signed and dated by the patient and/or by the parent(s) or legal representative
- Patient is a male or female ≥ 16 years of age
- Patient must have a diagnosis of brain tumor-related epilepsy (BTRE) secondary to low-grade glioma (World Health Organization Grade 1 to 2 at time of enrollment)
- Patient has a retrospective Baseline seizure frequency of at least 1 partial-onset seizure in the 8 weeks prior to Visit 1 (enrollment/ Baseline visit)
Show all 11Show fewer
- Patient does not have a previous diagnosis of epilepsy before tumor onset
- Patient does not have brain metastases
- Patient has a Karnofsky performance status scale index ≥ 60 %
- Patient is currently taking only 1-2 Baseline anti-epileptic drugs (AEDs) for epilepsy, other than LCM
- Patient has received a maximum of 4 different lifetime AEDs ever before entering the NIS
Who cannot join
- N/A
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
Italy9 sites
398
Ancona
397
Lecco
394
Milan
391
Perugia
392
Roma
396
Roma
395
San Fermo della Battaglia
393
Torino
399
Venezia
About this study
Official title: A Noninterventional Study of Vimpat® (Lacosamide) as Adjunctive Antiepileptic Drug Therapy in Patients With Brain Tumor-related Epilepsy
This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is effective in routine clinical practice for patients with epilepsy caused by a brain tumor.
- Conditions
- Brain Tumor Related Epilepsy (BTRE)
- Keywords
- Epilepsy, Brain tumor, lacosamide (LCM), Anti-Epileptic Drugs (AEDs)
- Medical subject headings
- Epilepsy, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BTRE patients | Patients with brain tumor-related epilepsy (BTRE) routinely treated with lacosamide as add on to one or two baseline anti-epileptic drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Response at the End of the 6-month Observation Period
A responder is a patient experiencing a 50 % or greater reduction in partial onset seizure frequency from Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Measured: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Patient Global Impression of Change (PGIC) Rating at Visit 3
The Patient Global Impression of Change scale is a seven-point scale for patients to rate their general health status at the end of the study compared to how they felt before entering the study. Scores 1 to 3 mean improvement, score 4 means no change, and scores 5 to 7 mean worsening.
The category 'Improved' represents the sum of Very Much Improved, Much Improved, and Minimally Improved.
The category 'Worsened' represents the sum of Minimally Worse, Much Worse, and Very Much Worse.
Measured: Visit 3 (Month 6 or end of Observation Period)
Secondary outcomes (11)
Percentage of Patients With Retention on Lacosamide (LCM) at the End of the 6-month Observation Period
The retention rate was defined as the percentage of patients remaining in the study and on Lacosamide treatment for 6 months (6 month retention rate).
Measured: Visit 3 (Month 6 or end of Observation Period)
Time to Discontinuation of Lacosamide (LCM) Treatment From the Date of First Dose of LCM
Time between first dose of LCM to discontinuation of LCM treatment was measured in days.
Measured: From first dose to discontinuation, over a 6-month Observation Period
Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in the 5 Level EuroQol-5 Dimension Quality of Life Assessment (EQ-5D-5L) Visual Analogue Scale (VAS) Score
EQ-5D-5L: 5 Level EuroQol-5 Dimension Quality of Life Assessment is a patient-completed questionnaire for patients to rate their quality of life status in five questions and a 0 (no pain) - 100 (worst pain) score vertical visual analogue scale. The Change from Baseline is calculated for this endpoint, negative values indicate improvement and positive values indicate worsening.
Measured: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in the 5 Level EuroQol-5 Dimension Quality of Life Assessment (EQ-5D-5L) Change in Utility as Converted From the 5 Dimensions
EQ-5D-5L: 5 Level EuroQol-5 descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression with five response levels for each dimension: no problems, slight problems, moderate problems, severe problems and extreme problems. This 5-dimension health status is converted into a numerical utility value using the UK value set, as per EuroQOL guidelines. The utility score ranges from 0 to 1 (0=worst imaginable health state, 1=best imaginable health state). The Change from Baseline is calculated for this endpoint, negative values indicate worsening and positive values indicate improvement.
Measured: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in the M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
MDASI-BT is a 2-part patient completed questionnaire where patients have to answer 22 questions about their brain tumor-related symptoms and 6 questions about how these symptoms interfere with their life. The mean core symptom severity is derived as the mean of the 13 core symptom items, the mean module symptom severity is derived as the mean of the 9 brain tumor specific symptom items and the mean total symptom severity is derived as the mean of all 22 symptom items. The mean interference is derived as the mean of the 6 interference items. For each score, at least 50% of the items needs to be answered for the score to be calculated. Mean core, mean module and mean total symptom severity scores are ranging from 0 to 10 (0=not present 10=as bad as you can imagine). Mean interference score is ranging from 0 to 10 (0= did not interfere 10= interfered completely). The Change from Baseline is calculated, negative values indicate improvement, positive values indicate worsening.
Measured: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Actual Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in Seizure Frequency (Seizures Per 28 Days)
The actual change in seizure frequency from Baseline to Month 6 is calculated as the seizure frequency at Month 6 minus the seizure frequence at Baseline.
The seizure frequency at each time point is calculated as number of seizures per 28 days.
Measured: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Percentage Change From Baseline in Seizure Frequency
The percentage change from Baseline to Month 6 in seizure frequency is the actual change in seizure frequency for this period compared to the Baseline seizure frequency, which is considered 100 %.
Measured: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Percentage of Patients With Seizure-free Status (Yes/No) at the End of the 6-month Observational Period
Percentage of patients achieving a seizure-free status at the end of the 6-month Observation Period.
Measured: Visit 3 (Month 6 or end of Observation Period)
Discontinuation Rate of Lacosamide (LCM) Due to Adverse Drug Reactions (ADRs)
Discontinuation rate due to ADRs is the number of patients that discontinued from the study and from LCM treatment due to ADRs during the 6 months of observation.
Measured: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Discontinuation Rate of Lacosamide (LCM) Due to Lack of Effectiveness
Discontinuation rate due to lack of effectiveness is the number of patients that discontinued from the study and from LCM treatment due to lack of effectiveness during the 6 months of observation.
Measured: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Clinical Global Impression of Change (CGIC) Rating at Visit 3 (Month 6 or End of Observation Period)
The Clinical Global Impression of Change is a seven-point scale for the treating physician to rate the patient's general health status at the end of the study compared to how the patient felt before entering the study. Scores 1 to 3 mean improvement, score 4 means no change, and scores 5 to 7 mean worsening.
The category 'Improved' represents the sum of Very Much Improved, Much Improved, and Minimally Improved.
The category 'Worsened' represents the sum of Minimally Worse, Much Worse, and Very Much Worse.
Measured: Visit 3 (Month 6 or end of Observation Period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study start27 Nov 2014
- Primary completion4 Dec 2017
- Study completion4 Dec 2017
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 Brain Tumor Related Epilepsy (BTRE)Studies 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276053
- Sponsor's protocol ID
- EP0045
- Acronym
- VIBES
- Status last verified
- May 2020
- First submitted
- 23 Oct 2014
- Last updated
- 1 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ruda R, Houillier C, Maschio M, Reijneveld JC, Hellot S, De Backer M, Chan J, Joeres L, Leunikava I, Glas M, Grant R. Effectiveness and tolerability of lacosamide as add-on therapy in patients with brain tumor-related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES). Epilepsia. 2020 Apr;61(4):647-656. doi: 10.1111/epi.16486.
PubMed 32329527
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Noninterventional Study of Vimpat® (Lacosamide) as Adjunctive Antiepileptic Drug Therapy in Patients With Brain Tumor-related Epilepsy
- ClinicalTrials.gov ID
- NCT02276053
- Acronym / sponsor ID
- VIBES / EP0045
- Conditions
- Brain Tumor Related Epilepsy (BTRE)
- Keywords
- Epilepsy, Brain tumor, lacosamide (LCM), Anti-Epileptic Drugs (AEDs)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES GmbHIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 27 Nov 2014 (actual)
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Posted 19 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is effective in routine clinical practice for patients with epilepsy caused by a brain tumor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTRE patients | – | –Patients with brain tumor-related epilepsy (BTRE) routinely treated with lacosamide as add on to one or two baseline anti-epileptic drugs. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients ≥ 16 years of age with brain tumor related epilepsy secondary to low grade tumor starting with lacosamide as add-on to one or two baseline anti-epileptic drugs.
Key inclusion criteria (11 listed)
- Patient has never been treated with lacosamide (LCM) prior to this non-interventional study (NIS) or treatment with LCM for the first time started no earlier than 7 days prior to enrollment in this NIS
- The decision by the treating physician to prescribe LCM falls within current standard clinical practice, and the treatment decision is clearly separated from the decision to consider inclusion of the patient in the NIS
- A Patient Data Consent form is signed and dated by the patient and/or by the parent(s) or legal representative
- Patient is a male or female ≥ 16 years of age
- Patient must have a diagnosis of brain tumor-related epilepsy (BTRE) secondary to low-grade glioma (World Health Organization Grade 1 to 2 at time of enrollment)
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.
Primary outcome
Percentage of Patients With Response at the End of the 6-month Observation Period
Time frame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
A responder is a patient experiencing a 50 % or greater reduction in partial onset seizure frequency from Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Patient Global Impression of Change (PGIC) Rating at Visit 3
Time frame: Visit 3 (Month 6 or end of Observation Period)
The Patient Global Impression of Change scale is a seven-point scale for patients to rate their general health status at the end of the study compared to how they felt before entering the study. Scores 1 to 3 mean improvement, score 4 means no change, and scores 5 to 7 mean worsening. The category 'Improved' represents the sum of Very Much Improved, Much Improved, and Minimally Improved. The category 'Worsened' represents the sum of Minimally Worse, Much Worse, and Very Much Worse.
11 secondary outcomes
Percentage of Patients With Retention on Lacosamide (LCM) at the End of the 6-month Observation Period
Time frame: Visit 3 (Month 6 or end of Observation Period)
Time to Discontinuation of Lacosamide (LCM) Treatment From the Date of First Dose of LCM
Time frame: From first dose to discontinuation, over a 6-month Observation Period
Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in the 5 Level EuroQol-5 Dimension Quality of Life Assessment (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Time frame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in the 5 Level EuroQol-5 Dimension Quality of Life Assessment (EQ-5D-5L) Change in Utility as Converted From the 5 Dimensions
Time frame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in the M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Time frame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Actual Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in Seizure Frequency (Seizures Per 28 Days)
Time frame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Percentage Change From Baseline in Seizure Frequency
Time frame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Percentage of Patients With Seizure-free Status (Yes/No) at the End of the 6-month Observational Period
Time frame: Visit 3 (Month 6 or end of Observation Period)
Discontinuation Rate of Lacosamide (LCM) Due to Adverse Drug Reactions (ADRs)
Time frame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Discontinuation Rate of Lacosamide (LCM) Due to Lack of Effectiveness
Time frame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
Clinical Global Impression of Change (CGIC) Rating at Visit 3 (Month 6 or End of Observation Period)
Time frame: Visit 3 (Month 6 or end of Observation Period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32329527Ruda R, Houillier C, Maschio M, Reijneveld JC, Hellot S, De Backer M, Chan J, Joeres L, Leunikava I, Glas M, Grant R. Effectiveness and tolerability of lacosamide as add-on therapy in patients with brain tumor-related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES). Epilepsia. 2020 Apr;61(4):647-656. doi: 10.1111/epi.16486.
- 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 Cares study director
+1 844 599 2273 (UCB)
24 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor Related Epilepsy (BTRE), run by UCB BIOSCIENCES GmbH at 24 sites in 6 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 11 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 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy, Germany, France, Netherlands, United Kingdom and 1 more country. 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 19 Aug 2019). 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?
Percentage of Patients With Response at the End of the 6-month Observation Period (time frame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)). The study lists 2 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 NCT02276053, 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 1 Jun 2020.