Seizure Prophylaxis Study
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|ClinicalTrials.gov Identifier: NCT03436433|
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioma Glioma of Brain Brain Tumor||Drug: Lacosamide Drug: Levetiracetam||Phase 2|
The protocol will assess the need for AED prophylaxis during the post-operative period in patients undergoing neurosurgical procedure for a suspected diagnosis of glioma (WHO grade I-IV) and brain metastasis. Patients (n=116) will be consented and randomized at their pre-operative assessment, either at their pre-operative clinic visit or in the ED, if that is the time of their initial presentation prior to surgery. There will be three arms to the study - patients will be randomized to LCM, LEV, or control (no AED). Randomization will be stratified by suspected grade (LGG vs HGG) and brain metastasis. The AED can be initiated anytime within 48 hours before neurosurgical procedure.
Doses will be either LCM 100mg twice a day (BID) (Arm A), LEV 1000mg BID (Arm B), or no AED (Arm C). If a patient is randomized to Arm C and undergoes tumor mapping, the patient is allowed to receive one dose of AED in the operating room. If a patient is randomized to Arm A or Arm B and takes the morning dose of their AED, they do not need an intra-operative dose of AED. If a patient has a seizure during the post-operative period, AEDs will be adjusted at the discretion of the treating physician. However, if a patient has intolerable side effects, patients will be changed to a different dose of the same medicine before consideration of another AED [i.e., BID to four times a day (QID) dosing if patient experiences diplopia on LCM].
Patients with high-grade tumors (newly-diagnosed or transformed) will be treated with standard radiation and temozolomide therapy per the Stupp protocol 25,70. For these patients, an AED taper will be initiated at the first clinic visit after completion of radiation. For patients with a low-grade tumor or recurrent disease of any grade or brain metastasis, an AED taper will be initiated at the first scheduled post-operative visit, approximately 6-10 weeks after the operation. LCM will be tapered by 100mg a week one week at a time. LEV will be tapered 500-1000mg one week at a time.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||232 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Upon consent, patients will be randomized in REDCap™ to receive either LCM, LEV, or no AED. Randomization will be stratified by suspected histologic grade (LGG vs HGG vs brain metastasis) based on MRI review by the treating neurosurgeon and/or neuro-oncologist. A stratified permuted block randomization algorithm will be used assign patients to treatment arms.|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Seizure Prophylaxis in Brain Tumor Patients Undergoing Neurosurgical Procedure|
|Actual Study Start Date :||January 31, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||January 31, 2021|
Active Comparator: Lacosamide
Enrolled subjects will be randomized to receive Lacosamide.
LCM 100mg twice a day.
Active Comparator: Levetiracetam
Enrolled subjects will be randomized to receive Levetiracetam.
LEV 1000mg twice a day.
No Intervention: No anti-epileptic
Enrolled subjects will be randomized to not receive anti-epileptic drugs.
- Percentage of patients with an ED visit/hospital readmission within 30 days of craniotomy [ Time Frame: 30 days following surgery ]The primary objective of this study is to assess the impact of LCM, LEV or, no AED in patients undergoing craniotomy for suspected new, recurrent or transformed glioma (WHO Gr I-IV) or brain metastasis.
- Adverse event within first 30 days after craniotomy [ Time Frame: 30 days following surgery ]Adverse events related to LCM and LEV.
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): NCT03436433
|Contact: Claudia Pamanesfirstname.lastname@example.org|
|Contact: Alexia Bwensaemail@example.com|
|United States, North Carolina|
|Duke Comprehensive Cancer Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853|
|Principal Investigator:||Annick Desjardins, M.D.||Duke University|