Randomized, Double-Blind, Placebo-Controlled Trial of Lacosamide for Seizure Prophylaxis in Patients With High-Grade Gliomas
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to receive either lacosamide or a placebo. Neither you nor your
doctor will know if you are receiving the study drug or placebo. However, if needed for
your safety during the study, the study staff and study doctor will be able to find out what
you are receiving.
You will take lacosamide or placebo by mouth 2 times a day, at about the same times each
day, spaced as close to 12 hours apart as possible. The study drug/placebo may be taken
with or without food. Missed doses should be only taken within 6 hours of the scheduled
time.
If you vomit while taking the study drug/placebo, you should not take more pills before the
next scheduled dose unless the pill can be clearly identified in the vomit.
You will be given a drug diary to fill out each day that you take the study pills. The
study staff will explain how to fill out this diary.
Study Visits:
Every month:
-You will be called and asked questions about any side effects you may be having. and about
your mood.
At Months 1, 4, 7, and 10:
- Your medical history will be recorded, including any drugs you may have taken and/or
may be taking.
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will have a neurological exam.
- At Months 4, 7, and 10, you will be asked about any side effects you may be having.
At any time during the study, extra tests may be performed if the doctor thinks they are
needed for your safety. The study doctor will tell you more about any extra tests.
Length of Study:
You may take lacosamide or placebo for up to 1 year. Your study doctor may take you off the
study early if he or she feels it is not in your best interest, you have new health problems
that make taking part in the study possibly dangerous, if intolerable side effects occur, or
if you are unable to follow study directions.
You will be considered off-study once you complete the Long-Term Follow-Up.
End-of-Dosing Visit:
After you stopped taking the study drug/placebo, you will have an end-of-dosing visit. At
this visit, the following tests and procedures will be performed:
- Your medical history will be recorded, including any drugs you may have taken and/or
may be taking and any side effects you may be having.
- You will complete the questionnaire about your mood.
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will have a neurological exam.
Long-Term Follow-Up:
Every 3 months after your End-of-Study visit, for about 5 years, you may be called and asked
how you are feeling if you do not schedule a required monthly follow up visit. This phone
call will take about 5-10 minutes.
This is an investigational study. Lacosamide is FDA approved and commercially available
for the treatment of seizures. Its use to reduce the risk of seizures in patients with
malignant gliomas is investigational.
Up to 302 patients will take part in this multicenter study. Up to 60 will be enrolled at
MD Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Time to First Seizure (TFS)
The primary measure of efficacy is time to first seizure (TFS). The primary test of the difference in TFS between the treatment arms based on the likelihood ratio statistic for the treatment effect in a stratified proportional hazards regression model with anticonvulsant use as the stratification factor. The conditional power for the time-to-event outcome computed based on the method described in Design and Analysis of Clinical Trials with Time-to-Event Endpoints and Lan Simon and Halperin.
1 month
Yes
Mark R. Gilbert, MD,BS
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
BTTC11-01
NCT01432171
July 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |