Neoplasms

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Glioma

Seizures

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neurologic Manifestations

Neuroepithelioma

Channel Blockers

Anticonvulsants

All Drugs and Chemicals

Lacosamide

Sodium Channel Blockers

Diuretics, Potassium Sparing

Participants receive lacosamide PO BID for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

Participants receive a placebo PO BID for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

Placebo

Marta Penas-Prado

This trial studies how well lacosamide works in preventing seizures in participants with malignant glioma. Anti-seizure drugs, such as lacosamide, may decrease abnormal electrical activity in the brain that plays a role in developing seizures.

PRIMARY OBJECTIVES:

I. To determine if prophylactic administration of Lacosamide reduces the risk of seizures in patients with high-grade glioma (HGG).

SECONDARY OBJECTIVES:

I. To determine the one-year risk of first seizure in this patient population. II. To evaluate patient reported symptoms.

EXPLORATORY OBJECTIVES:

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.

Lacosamide in Preventing Seizures in Participants With Malignant Glioma

Randomized, Double-Blind, Placebo-Controlled Trial of Lacosamide for Seizure Prophylaxis in Patients With High-Grade Gliomas

Number of Participants that had seizure in a randomized, two-arm, parallel groups of post-operative participants with newly-diagnosed high-grade glioma (HGG)

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Lacosamide orally twice a day, starting dose 50 mg with dose escalation (increased by 100 mg/day weekly) until target dose 200 mg achieved over 4 weeks

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

This is a cooperative group protocol. It was not an MDACC protocol. BTTC was administratively located at MDACC. The main PI/Academic PI was located at an outside institution.

Dr. Andrew Norden, M.D., M.P.H. - Lead Principal Investigator

Number of Participants With Seizures

Lacosamide (Vimpat)

Overall Study

Peripheral Nervous System Diseases

Neuromuscular Diseases

Antineoplastic Agents

Analgesics

Psychotropic Drugs

Central Nervous System Depressants

Vasoconstrictor Agents

Cardiotonic Agents

Oxaliplatin

Duloxetine Hydrochloride

Gabapentin

Anti-Anxiety Agents

Excitatory Amino Acid Antagonists

Neurotransmitter Agents

Norepinephrine

Serotonin

Serotonin and Noradrenaline Reuptake Inhibitors

Antidepressive Agents

Dopamine

Dopamine Agents

Duloxetine 30mg / day for 12 cycles (up to 6 months)

Duloxetine

Gabapentin 300 mg / day for 12 cycles (up to 6 months)

Lacosamide 50 mg / day for 12 cycles (up to 6 months)

Sally Said, MSC

Osama Ibrahim, phd

This study aims to investigate the possible efficacy of duloxetine, gabapentin and lacosamide on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer.

This is a randomized, double-blind,controlled, parallel study that will be conducted on patients with oxaliplatin induced peripheral neuropathy with gastrointestinal cancer.

This study will be done on 93 patients with gastrointestinal cancer (colon or gastric or pancreatic) cancer on standard FOLFOX-4 regimen who will divided into 3 groups:

Group 1: 31 Patients who will receive standard chemotherapy plus duloxetine 30 mg/day for 12 cycles (up to 6 months).

Group 2: 31 Patients who will receive standard chemotherapy plus gabapentin 300 mg/day for 12 cycles (up to 6 months).

Group 3: 31 Patients who will receive standard chemotherapy plus lacosamide 50 mg/day for 12 cycles (up to 6 months).

Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients

Tanta University

Clinical Pharmacist

Brain Neoplasms

Neoplasm Metastasis

Epilepsy

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Nootropic Agents

Levetiracetam

Enrolled subjects will be randomized to receive Lacosamide.

Enrolled subjects will be randomized to receive Levetiracetam.

Enrolled subjects will be randomized to not receive anti-epileptic drugs.

Annick Desjardins, M.D.

This protocol is designed to assess the need for seizure prophylaxis in the perioperative period for patients undergoing neurosurgical procedure (gross-total resection, sub-total resection or biopsy) for suspected diagnosis of new, recurrent or transformed glioma (WHO grade I-IV) and brain metastasis. This will be determined by observing the impact of Lacosamide (LCM), Levetiracetam (LEV), or no anti-epileptic drug (AED) on whether visits to the emergency department (ED) or hospital re-admissions occur within 30 days after procedure. A secondary endpoint will evaluate the safety and tolerability of LCM and LEV. Exploratory endpoints will evaluate admission duration for the procedure, number of post-operative provider communications (telephone, email, and additional clinic encounters, etc.), and patient risk factors associated with post-operative seizure.

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.

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.

Seizure Prophylaxis in Patients With Glioma or Brain Metastasis

Phase II Trial of Seizure Prophylaxis in Brain Tumor Patients Undergoing Neurosurgical Procedure

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 on ED visits and readmissions within 30 days of craniotomy.

Adverse events related to LCM, LEV, and no drug within first 30 days after craniotomy.

Duke University

Enrolled subjects will be randomized to receive Lacosamide.

Lacosamide: LCM 100mg twice a day.

Enrolled subjects will be randomized to receive Levetiracetam.

Levetiracetam: LEV 1000mg twice a day.

No Anti-epileptic

Race

Race/Ethnicity, Customized

Anxiety

This study was limited by the small sample size, and a dataset with a larger sample size should be used to further evaluate the impact of LCM, LEV, and no antiepileptic drugs on adverse events, ED visits and hospital readmissions in the future.

Claudia E. Pamanes, MPH, CCRP

Percentage of Patients With an ED Visit/Hospital Readmission Within 30 Days of Craniotomy

Dizziness

Somnolence

Cognitive disturbance

Nausea

Vomiting

Ataxia

Suicide thought

Suicide attempt

Depression

Irritability

Psychosis

Personality change

Number of Participants With an Adverse Event Within First 30 Days After Craniotomy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lacosamide in Preventing Seizures in Participants With Malignant Glioma	NCT01432171	Malignant Gliom...	Lacosamide Placebo	18 Years -	M.D. Anderson Cancer Center
Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients	NCT05510856	Oncology	Duloxetine Gabapentin Lacosamide	18 Years -	Tanta University
Seizure Prophylaxis in Patients With Glioma or Brain Metastasis	NCT03436433	Glioma Glioma of Brain Brain Tumor	Lacosamide Levetiracetam	18 Years - 99 Years	Duke University
Seizure Prophylaxis in Patients With Glioma or Brain Metastasis	NCT03436433	Glioma Glioma of Brain Brain Tumor	Lacosamide Levetiracetam	18 Years - 99 Years	Duke University

Spots Global Cancer Trial Database for lacosamide

Every month we try and update this database with for lacosamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lacosamide

Every month we try and update this database with for lacosamide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lacosamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.