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

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.

Time frame: Visit 3 (Month 6 or end of Observation Period)

Population: The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.

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)

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

Population: The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.

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.

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

Population: The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.

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.

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

Population: The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.

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.

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

Population: The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.

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.

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

Population: The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.

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.

Time frame: Visit 3 (Month 6 or end of Observation Period)

Population: The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.

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.

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

Population: The analysis was performed on the Safety Set (SS), which included all patients who received treatment with lacosamide (LCM) at least once in the study.

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.

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

Population: The analysis was performed on the Safety Set (SS), which included all patients who received treatment with lacosamide (LCM) at least once in the study.

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 %.

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

Population: The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.

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 frame: Visit 3 (Month 6 or end of Observation Period)

Population: The analysis was performed on the Safety Set (SS), which included all patients who received treatment with lacosamide (LCM) at least once in the study.

Percentage of patients achieving a seizure-free status at the end of the 6-month Observation Period.

Time frame: Visit 3 (Month 6 or end of Observation Period)

Population: The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.

Time between first dose of LCM to discontinuation of LCM treatment was measured in days.

Time frame: From first dose to discontinuation, over a 6-month Observation Period

Population: The analysis was performed on the Safety Set (SS), which included all patients who received treatment with lacosamide (LCM) at least once in the study.