Lacosamide in Preventing Seizures in Participants With Malignant Glioma
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|ClinicalTrials.gov Identifier: NCT01432171|
Recruitment Status : Terminated
First Posted : September 12, 2011
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Drug: Lacosamide Other: Placebo||Not Applicable|
I. To determine if prophylactic administration of Lacosamide reduces the risk of seizures in patients with high-grade glioma (HGG).
I. To determine the one-year risk of first seizure in this patient population. II. To evaluate patient reported symptoms.
I. To investigate clinical and electroencephalographic predictors of seizures in this patient population.
II. To evaluate the occurrence of symptoms and correlate to seizure activity as well as tolerance to treatment using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) self-reporting tool.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (LACOSAMIDE): Participants receive lacosamide orally (PO) twice a day (BID) for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM II (PLACEBO): Participants receive a placebo PO BID for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up every 3 months for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double-Blind, Placebo-Controlled Trial of Lacosamide for Seizure Prophylaxis in Patients With High-Grade Gliomas|
|Actual Study Start Date :||July 25, 2012|
|Actual Primary Completion Date :||June 20, 2017|
|Actual Study Completion Date :||June 20, 2017|
Experimental: Arm I (lacosamide)
Participants receive lacosamide PO BID for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.
Placebo Comparator: Arm II (placebo)
Participants receive a placebo PO BID for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.
- Number of Participants With Seizures [ Time Frame: 12 months or first seizure ]Number of Participants that had seizure in a randomized, two-arm, parallel groups of post-operative participants with newly-diagnosed high-grade glioma (HGG)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432171
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Marta Penas-Prado||M.D. Anderson Cancer Center|