N/A
N=93
Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors
Brain Tumor Related Epilepsy (BTRE)
Bottom Line
View on ClinicalTrials.gov: NCT02276053 ↗Enrolled (actual)
93
Serious AEs
5.4%
Results posted
Aug 2019
Primary outcome: Primary: Percentage of Patients With Response at the End of the 6-month Observation Period — 76.7 percentage of patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- UCB BIOSCIENCES GmbH
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Response at the End of the 6-month Observation Period |
76.7 | — |
| PRIMARY Patient Global Impression of Change (PGIC) Rating at Visit 3 |
49; 17; 10 | — |
| SECONDARY Percentage of Patients With Retention on Lacosamide (LCM) at the End of the 6-month Observation Period |
63.4 | — |
| SECONDARY Time to Discontinuation of Lacosamide (LCM) Treatment From the Date of First Dose of LCM |
NA | — |
| 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 |
1.3 | — |
| 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 |
-0.01 | — |
| 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) |
0.1; -0.1; 0.0; -0.5 | — |
| SECONDARY Actual Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in Seizure Frequency (Seizures Per 28 Days) |
-2.9 | — |
| SECONDARY Percentage Change From Baseline in Seizure Frequency |
-85.2 | — |
| SECONDARY Percentage of Patients With Seizure-free Status (Yes/No) at the End of the 6-month Observational Period |
34.9 | — |
| SECONDARY Discontinuation Rate of Lacosamide (LCM) Due to Adverse Drug Reactions (ADRs) |
5 | — |
| SECONDARY Discontinuation Rate of Lacosamide (LCM) Due to Lack of Effectiveness |
7 | — |
| SECONDARY Clinical Global Impression of Change (CGIC) Rating at Visit 3 (Month 6 or End of Observation Period) |
52; 19; 10 | — |
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
Data sourced from ClinicalTrials.gov (NCT02276053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.