Clinical trial NCT02276053: Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors
Official title: A Noninterventional Study of Vimpat® (Lacosamide) as Adjunctive Antiepileptic Drug Therapy in Patients With Brain Tumor-related Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor Related Epilepsy (BTRE)
Keywords: Epilepsy
Brain tumor
lacosamide (LCM)
Anti-Epileptic Drugs (AEDs)
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2014-10-27
Enrollment: 93
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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)
* 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:

* N/A

Primary outcomes:
measure: Percentage of Patients With Response at the End of the 6-month Observation Period
timeFrame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
measure: Patient Global Impression of Change (PGIC) Rating at Visit 3
timeFrame: Visit 3 (Month 6 or end of Observation Period)
Secondary outcomes:
measure: Percentage of Patients With Retention on Lacosamide (LCM) at the End of the 6-month Observation Period
timeFrame: Visit 3 (Month 6 or end of Observation Period)
measure: Time to Discontinuation of Lacosamide (LCM) Treatment From the Date of First Dose of LCM
timeFrame: From first dose to discontinuation, over a 6-month Observation Period
measure: 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
timeFrame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
measure: 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
timeFrame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
measure: 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)
timeFrame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
measure: Actual Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in Seizure Frequency (Seizures Per 28 Days)
timeFrame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
measure: Percentage Change From Baseline in Seizure Frequency
timeFrame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
measure: Percentage of Patients With Seizure-free Status (Yes/No) at the End of the 6-month Observational Period
timeFrame: Visit 3 (Month 6 or end of Observation Period)
measure: Discontinuation Rate of Lacosamide (LCM) Due to Adverse Drug Reactions (ADRs)
timeFrame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
measure: Discontinuation Rate of Lacosamide (LCM) Due to Lack of Effectiveness
timeFrame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
measure: Clinical Global Impression of Change (CGIC) Rating at Visit 3 (Month 6 or End of Observation Period)
timeFrame: Visit 3 (Month 6 or end of Observation Period)
Other outcomes:
Locations:
city: Lille
country: France
facility: 337
city: Lyon Cedex
country: France
facility: 334
city: Paris Cedex 13
country: France
facility: 335
city: Bonn
country: Germany
facility: 491
city: Freiburg
country: Germany
facility: 493
city: Regensburg
country: Germany
facility: 492
city: Tübingen
country: Germany
facility: 494
city: Ancona
country: Italy
facility: 398
city: Lecco
country: Italy
facility: 397
city: Milano
country: Italy
facility: 394
city: Perugia
country: Italy
facility: 391
city: Roma
country: Italy
facility: 392
city: Roma
country: Italy
facility: 396
city: San Fermo Della Battaglia
country: Italy
facility: 395
city: Torino
country: Italy
facility: 393
city: Venezia
country: Italy
facility: 399
city: Amsterdam
country: Netherlands
facility: 311
city: Leidschendam
country: Netherlands
facility: 312
city: Tilburg
country: Netherlands
facility: 314
city: Badalona
country: Spain
facility: 341
city: Barcelona
country: Spain
facility: 344
city: Edgbaston
country: United Kingdom
facility: 443
city: Edinburgh
country: United Kingdom
facility: 441
city: London
country: United Kingdom
facility: 442
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: 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.