Brain Tumor Related Epilepsy (BTRE) Clinical Trial
— VIBESOfficial title:
A Noninterventional Study of Vimpat® (Lacosamide) as Adjunctive Antiepileptic Drug Therapy in Patients With Brain Tumor-related Epilepsy
| NCT number | NCT02276053 |
| Other study ID # | EP0045 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 27, 2014 |
| Est. completion date | December 4, 2017 |
| Verified date | May 2020 |
| Source | UCB Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 93 |
| Est. completion date | December 4, 2017 |
| Est. primary completion date | December 4, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | 337 | Lille | |
| France | 334 | Lyon Cedex | |
| France | 335 | Paris Cedex 13 | |
| Germany | 491 | Bonn | |
| Germany | 493 | Freiburg | |
| Germany | 492 | Regensburg | |
| Germany | 494 | Tübingen | |
| Italy | 398 | Ancona | |
| Italy | 397 | Lecco | |
| Italy | 394 | Milano | |
| Italy | 391 | Perugia | |
| Italy | 392 | Roma | |
| Italy | 396 | Roma | |
| Italy | 395 | San Fermo Della Battaglia | |
| Italy | 393 | Torino | |
| Italy | 399 | Venezia | |
| Netherlands | 311 | Amsterdam | |
| Netherlands | 312 | Leidschendam | |
| Netherlands | 314 | Tilburg | |
| Spain | 341 | Badalona | |
| Spain | 344 | Barcelona | |
| United Kingdom | 443 | Edgbaston | |
| United Kingdom | 441 | Edinburgh | |
| United Kingdom | 442 | London |
| Lead Sponsor | Collaborator |
|---|---|
| UCB BIOSCIENCES GmbH | PRA Health Sciences |
France, Germany, Italy, Netherlands, Spain, United Kingdom,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | 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 | 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). | Visit 3 (Month 6 or end of Observation Period) | |
| Secondary | 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. | From first dose to discontinuation, over a 6-month Observation Period | |
| Secondary | 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. | Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period) | |
| Secondary | 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. | Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period) | |
| Secondary | 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. | Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period) | |
| Secondary | 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. |
Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period) | |
| Secondary | 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 %. | Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period) | |
| Secondary | 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. | Visit 3 (Month 6 or end of Observation Period) | |
| Secondary | 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. | Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period) | |
| Secondary | 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. | Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period) | |
| Secondary | 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. |
Visit 3 (Month 6 or end of Observation Period) |