NCT02276053

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
6 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

November 27, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 19, 2019

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

3 years

First QC Date

October 23, 2014

Results QC Date

December 4, 2018

Last Update Submit

May 15, 2020

Conditions

Brain Tumor Related Epilepsy (BTRE)

Keywords

EpilepsyBrain tumorlacosamide (LCM)Anti-Epileptic Drugs (AEDs)

Outcome Measures

Primary Outcomes (2)

  • 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)

    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.

    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

    Visit 3 (Month 6 or end of Observation Period)

  • Time to Discontinuation of Lacosamide (LCM) Treatment From the Date of First Dose of LCM

    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

    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

    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)

    Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)

  • +6 more secondary outcomes

Study Arms (1)

BTRE patients

Patients with brain tumor-related epilepsy (BTRE) routinely treated with lacosamide as add on to one or two baseline anti-epileptic drugs.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

337

Lille, France

Location

334

Lyon, France

Location

335

Paris, France

Location

491

Bonn, Germany

Location

493

Freiburg im Breisgau, Germany

Location

492

Regensburg, Germany

Location

494

Tübingen, Germany

Location

398

Ancona, Italy

Location

397

Lecco, Italy

Location

394

Milan, Italy

Location

391

Perugia, Italy

Location

392

Roma, Italy

Location

396

Roma, Italy

Location

395

San Fermo della Battaglia, Italy

Location

393

Torino, Italy

Location

399

Venezia, Italy

Location

311

Amsterdam, Netherlands

Location

312

Leidschendam, Netherlands

Location

314

Tilburg, Netherlands

Location

341

Badalona, Spain

Location

344

Barcelona, Spain

Location

443

Edgbaston, United Kingdom

Location

441

Edinburgh, United Kingdom

Location

442

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 32329527BACKGROUND

Related Links

MeSH Terms

Conditions

EpilepsyBrain Neoplasms

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasms

Results Point of Contact

Title
UCB
Organization
Cares
UCBCares@ucb.com
+1844 599

Study Officials

  • UCB Cares

    +1 844 599 2273 (UCB)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2014

First Posted

October 27, 2014

Study Start

November 27, 2014

Primary Completion

December 4, 2017

Study Completion

December 4, 2017

Last Updated

June 1, 2020

Results First Posted

August 19, 2019

Record last verified: 2020-05

Locations

GB(3)ES(2)FR(3)DE(4)IT(9)NL(3)