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Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors (VIBES)

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ClinicalTrials.gov Identifier: NCT02276053
Recruitment Status : Completed
First Posted : October 27, 2014
Results First Posted : August 19, 2019
Last Update Posted : June 1, 2020
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Tracking Information
First Submitted Date October 23, 2014
First Posted Date October 27, 2014
Results First Submitted Date December 4, 2018
Results First Posted Date August 19, 2019
Last Update Posted Date June 1, 2020
Actual Study Start Date November 27, 2014
Actual Primary Completion Date December 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2019)
  • 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.
Original Primary Outcome Measures
 (submitted: October 24, 2014)
  • 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 means improvement, score 4 means no change, and scores 5 to 7 means worsening.
Change History
Current Secondary Outcome Measures
 (submitted: July 11, 2019)
  • 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) ]
    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).
  • 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 ]
    Time between first dose of LCM to discontinuation of LCM treatment was measured in days.
  • 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) ]
    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.
  • 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) ]
    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.
  • 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) ]
    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.
  • 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) ]
    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.
  • Percentage Change From Baseline in Seizure Frequency [ Time Frame: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period) ]
    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 %.
  • 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) ]
    Percentage of patients achieving a seizure-free status at the end of the 6-month 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 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.
  • 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) ]
    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.
  • 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) ]
    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.
Original Secondary Outcome Measures
 (submitted: October 24, 2014)
  • Retention on lacosamide (LCM) at the end of the 6-month Observation Period [ Time Frame: Visit 3 (Month 6 or end of Observation Period) ]
    Retention rate is the number and percentage of patients remaining in the study and on LCM treatment for 6 months (6 month retention rate).
  • Time to Discontinuation of Lacosamide (LCM) Treatment From the Date of First Dose of LCM [ Time Frame: First dose to discontinuation ]
    Time between first dose of Vimpat to discontinuation of LCM treatment.
  • 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) ]
    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 - 100 score vertical visual analogue scale.
  • 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) ]
    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 - 100 score vertical visual analogue scale.
  • 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) ]
    MDASI-BT: M.D. Anderson Symptom Inventory - Brain Tumor is a two-part patient completed questionnaire where patients have to answer 22 questions about their brain tumor-related symptoms on a scale from 0 to 10 (part 1) and six questions about how these symptoms interfere with their life on a scale from 0 to 10 (part 2).
  • 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) ]
    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.
  • Percentage Change From Baseline in Seizure Frequency [ Time Frame: Baseline to Visit 3 (Month 6 or end of Observation Period) ]
    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 %.
  • 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) ]
    Number and percentage of patients achieving a seizure-free status at the end of the 6-month Observation Period.
  • Discontinuation Rate of Lacosamide (LCM) Due to Adverse Drug Reactions (ADRs) [ Time Frame: Baseline to Visit 3 (Month 6 or end of Observation Period) ]
    Discontinuation rate due to ADRs is the number and percentage of patients that discontinued from the study and from LCM treatment due to ADRs during the 6 months of observation.
  • Discontinuation Rate of Lacosamide (LCM) Due to Lack of Effectiveness [ Time Frame: Baseline to Visit 3 (Month 6 or end of Observation Period) ]
    Discontinuation rate due to lack of effectiveness is the number and percentage of patients that discontinued from the study and from LCM treatment due to lack of effectiveness during the 6 months of observation.
  • 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) ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Brain Tumor Related Epilepsy (BTRE)
Intervention Not Provided
Study Groups/Cohorts BTRE patients
Patients with brain tumor-related epilepsy (BTRE) routinely treated with lacosamide as add on to one or two baseline anti-epileptic drugs.
Publications * Rudà 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 17, 2017)
93
Original Estimated Enrollment
 (submitted: October 24, 2014)
100
Actual Study Completion Date December 4, 2017
Actual Primary Completion Date December 4, 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02276053
Other Study ID Numbers EP0045
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party UCB Pharma ( UCB BIOSCIENCES GmbH )
Study Sponsor UCB BIOSCIENCES GmbH
Collaborators PRA Health Sciences
Investigators
Study Director: UCB Cares +1 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date May 2020