Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors
NCT ID: NCT02276053
Last Updated: 2020-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
93 participants
OBSERVATIONAL
2014-11-27
2017-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BTRE patients
Patients with brain tumor-related epilepsy (BTRE) routinely treated with lacosamide as add on to one or two baseline anti-epileptic drugs.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
Exclusion Criteria
16 Years
ALL
No
Sponsors
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PRA Health Sciences
INDUSTRY
UCB BIOSCIENCES GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
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337
Lille, , France
334
Lyon, , France
335
Paris, , France
491
Bonn, , Germany
493
Freiburg im Breisgau, , Germany
492
Regensburg, , Germany
494
Tübingen, , Germany
398
Ancona, , Italy
397
Lecco, , Italy
394
Milan, , Italy
391
Perugia, , Italy
392
Roma, , Italy
396
Roma, , Italy
395
San Fermo della Battaglia, , Italy
393
Torino, , Italy
399
Venezia, , Italy
311
Amsterdam, , Netherlands
312
Leidschendam, , Netherlands
314
Tilburg, , Netherlands
341
Badalona, , Spain
344
Barcelona, , Spain
443
Edgbaston, , United Kingdom
441
Edinburgh, , United Kingdom
442
London, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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EP0045
Identifier Type: -
Identifier Source: org_study_id
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