Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Seizures

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Neoplasms

Neurologic Manifestations

Brain Diseases

Central Nervous System Diseases

Anticonvulsants

Nootropic Agents

All Drugs and Chemicals

Levetiracetam

levetiracetam

quality-of-life assessment

Jeffrey J. Raizer, MD

RATIONALE: Anticonvulsant drugs, such as levetiracetam, may help control seizures caused by brain metastases.

PURPOSE: This clinical trial is studying the side effects and how well levetiracetam works in treating patients with seizures caused by brain metastases.

OBJECTIVES:

* Determine the optimal dose of levetiracetam required to control seizures from brain metastases in patients with solid tumors.
* Determine the frequency of side effects and tolerability of this drug when used to control seizures in these patients.
* Determine any improvement in antiepileptic drug-associated symptoms in these patients.

OUTLINE: This is a pilot study. Patients are stratified according to baseline seizures (yes vs no) and/or baseline antiepileptic drugs (AEDs) (yes vs no). Patients are assigned to 1 of 3 treatment groups.

* Group I (patients with no active baseline seizures): Patients receive oral levetiracetam twice daily beginning on day 1.
* Group II (patients requiring IV AEDs for baseline seizure control): Patients receive oral levetiracetam (instead of their current anticonvulsant therapy) twice daily beginning on day 1, after their presenting condition has stabilized.
* Group III (patients with active seizures controlled by other concurrent anticonvulsant monotherapy): Patients receive oral levetiracetam (instead of their current anticonvulsant therapy) twice daily beginning on day 1. Treatment with the other anticonvulsant drug is tapered beginning on day 3 as directed by the treating physician.

In all groups, treatment continues for up to 6 months in the absence of uncontrolled seizures or unacceptable toxicities.

During study therapy, patients maintain a seizure log that tracks frequency and type of seizures. Any patient who experiences a breakthrough seizure or multiple auras receives increasing doses of oral levetiracetam until the maximum dose is reached. Patients who continue to have seizures at the maximum dose level receive a second antiseizure medication at the discretion of the treating physician.

Quality of life is assessed by the Fundamental Assessment of Cancer Treatment-Brain questionnaire at baseline and at 2 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases

National Cancer Institute (NCI)

Northwestern University

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Musculoskeletal Diseases

Digestive System Diseases

Heart and Blood Diseases

Prostatic Neoplasms

Hemorrhage

Arthritis

Liver Neoplasms

Thromboembolism

Joint Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Coagulants

Central Nervous System Depressants

Tranexamic Acid

Anesthetics

Empirical Tranexamic acid (TXA) administration after the anesthesia induction

When LY30≥3% or MA\<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered

When LY30\<3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered

TEG6

Tae-Yop Kim

Wooseul Lee

Tae-yop Kim, M.D, PhD

Tae-Yop Kim, MD PhD

Tae-Yop Kim, MD, PhD

The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. This study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in non-cardiac surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, during postoperative 2bleeding, thromboembolic complications, and postoperative seizures. Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks.

randomized prospective multicenter non-inferior

Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery

Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery

number of unit, transfused fresh frozen plasma

number of unit, transfused cryoprecipitate

number of unit, transfused platelet (apheresis) or platelet concentrate

incidence of postoperative myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction

incidence of re-operation due to postoperative bleeding

Korea Health Industry Development Institute

Asan Medical Center

Soon Chun Hyang University

Konkuk University Medical Center

Professor of Anesthesiology

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants received 160 mg of enzalutamide orally once a day, for 4 months. At the end of the 4-month treatment period, participants who were assessed as deriving benefit from enzalutamide treatment continued in the extension period. The total study drug treatment duration for the extended period depended on individual clinical benefit. If a participant experienced a Grade 3 or higher toxicity that was attributed to enzalutamide and could not be ameliorated by the use of adequate medical intervention, treatment with enzalutamide was allowed to be interrupted for 1 week or until the toxicity grade improved to Grade 2 or lower severity. Subsequently, enzalutamide was restarted at the original dose 160 mg per day or a reduced dose 120 or 80 mg per day in consultation with the medical monitor.

Participants received 4 capsules (40 mg each) of enzalutamide orally once a day, for a total daily dose of 160 mg. Treatment was given with or without food and as close as possible to the same time each day.

Enzalutamide

Sr. Medical Director

The objective of this study was to evaluate the incidence of seizures and monitor the safety of enzalutamide treatment in participants with metastatic castration-resistant prostate cancer (mCRPC) known to have risk factor(s) for seizure.

This was a multicenter, single-arm, open-label, postmarketing safety study to evaluate the risk of seizure among patients with mCRPC treated with enzalutamide who were at potential increased risk of seizure.

Participants who met all inclusion and none of the exclusion criteria were enrolled into the study and participated in a 4-month treatment period, during which once daily dosing of enzalutamide (160 mg/day) occurred. At the end of the 4-month treatment period, participants who were assessed as deriving benefit from enzalutamide treatment were allowed to continue in the extension period where participants continued to receive enzalutamide until 1 of the following criteria was met:

1. The participant experienced bone disease progression per Prostate Cancer Working Group 2 (PCWG2) guidelines or soft tissue disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
2. The participant initiated treatment with another anticancer therapy or, in the opinion of the investigator, continued dosing would have led to undue risk to the patient
3. The participant met a discontinuation criterion
4. The sponsor terminated the study

Participants who continued to receive clinical benefit from treatment with enzalutamide and did not meet any discontinuation criteria may have transitioned to an open label roll-over extension study upon approval of the study protocol at the institution where they were receiving treatment.

Participants who did not continue in the extension period or who met a discontinuation criterion were discontinued from enzalutamide therapy and completed a follow-up visit 30 days from the last dose of enzalutamide or prior to the initiation of another anticancer therapy, whichever occurred first.

For participants who continued on treatment after the 12-month extension period, data collection was limited to dosing information, concomitant medications, and all adverse events (AEs) including serious adverse events (SAEs).

A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide

A Multicenter, Single-arm, Open-label, Postmarketing Safety Study to Evaluate the Risk of Seizure Among Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated With Enzalutamide Who Are at Potential Increased Risk of Seizure

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Percentage of evaluable participants with at least one confirmed seizure as adjudicated by the IAC during the first 4 months of treatment were reported.

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Astellas Pharma Global Development, Inc.

Enzalutamide 160 mg

Participants received 160 mg of enzalutamide orally once a day, for 4 months.

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Ethnicity

Grade 0

Grade 1

Grade 2

ECOG performance status is a scale used to measure disease progression and impact on daily activities. Scores range from 0 to 5, with grade 0- signifying fully active participant, grade 1-restricted in physically strenuous activity; grade 2 - ambulatory and capable of all self-care, unable to work; grade 3- capable of only limited self-care, confined to bed more than 50% of waking hours; grade 4-completely disabled and grade 5- dead.

Eastern Cooperative Oncology Group (ECOG) At Study Entry

The safety analysis set (SAF) consisted of all participants who took at least 1 dose of study drug and for whom any data was reported after first dose of study drug.

After completing the extension period participants who were assessed to benefit from enzalutamide completed their treatment in another Astellas study, 9785-CL-0123 (NCT02960022).

Clinical Trial Disclosure

The seizure risk evaluation set (SRES) consisted of all participants with a confirmed seizure during the 4-month treatment period of the study or who completed at least 3 months (75 percent \[%\]) of the planned treatment.

The Percentage of Evaluable Participants With at Least One Confirmed Seizure as Adjudicated by the Independent Adjudication Committee (IAC)

4 Month Treatment Period

1 Year Extension Period

Post 1 Year Extension Period

Rare Diseases

Recurrence

Glioblastoma

Glioma

Medulloblastoma

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Meningioma

Pinealoma

Astrocytoma

Ependymoma

Oligodendroglioma

Gliosarcoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Brain Tumor, Adult

Pineocytoma

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Neuroepithelioma

Diffuse Astrocytoma

Supratentorial Primitive Neuroectodermal Tumor

Pineoblastoma

Anaplastic Ependymoma

Embryonal Tumor With Multilayered Rosettes

Channel Blockers

Analgesics

Psychotropic Drugs

Bone Density Conservation Agents

Pregabalin

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Anti-Anxiety Agents

Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year

Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year

After inclusion, patients receive Levetiracetam 2x250mg per day. The medication may be increased, in intervals of 500mg of Levetiracetam of at least 24h up to maximally: Levetiracetam 2x1500mg.

Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study.

After inclusion, patients receive Pregabalin 2x75mg per day. The medication may be increased, in intervals of 150mg of Pregabalin of at least 24h up to maximally: Pregabalin 2x300mg.

Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study.

pregabalin

Andrea O. Rossetti, MD

RATIONALE: Levetiracetam and pregabalin are drugs that treat seizures. It is not yet known which drug is more effective in treating seizures caused by primary brain tumors.

PURPOSE: This randomized phase II trial is studying the side effects and how well levetiracetam or pregabalin work in treating seizures in patients undergoing chemotherapy and/or radiation therapy for primary brain tumors.

OBJECTIVES:

* To determine the safety and efficacy of antiepileptic drug monotherapy comprising levetiracetam or pregabalin in treating seizures in patients undergoing chemotherapy and/or radiotherapy for primary brain tumors.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive levetiracetam.
* Arm II: Patients receive pregabalin. Patients are followed at 2 weeks, 2 months, 6 months, and then at 1 year.

Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors

Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.

Dr Andrea Rossetti

Médecin associé

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Sclerosis

Syndrome

Muscle Cramp

Spasm

Epilepsy

Lennox Gastaut Syndrome

Tuberous Sclerosis

Spasms, Infantile

Epilepsies, Myoclonic

Hamartoma

Neoplasms, Multiple Primary

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Epilepsy, Generalized

Epileptic Syndromes

Dravet Syndrome

CDKL5 Deficiency Disorder

Lennox-Gastaut Syndrome

Tuberous Sclerosis Complex

West Syndrome

Pharmaceutical Solutions

Cannabidiol

The 52-week treatment period includes a fixed 2-week titration schedule followed by flexible dose optimization.

Day 1: 5 mg/kg/day (2.5 mg/kg twice daily (b.i.d.))

Day 8: 10 mg/kg/day (5 mg/kg b.i.d.)

Day 15 to Week 52: Flexible dosing based on the participant's observed efficacy, safety, and tolerability per the investigator's clinical judgement. Up to a maximum of 20 mg/kg/day (10 mg/kg b.i.d.) for LGS and DS or 25 mg/kg/day (12.5 mg/kg b.i.d.) for TSC, in maximum weekly increments of 5 mg/kg/day (≤ 2.5 mg/kg b.i.d.).

GWP42003-P

Clinical Trial Disclosure & Transparency

This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants \< 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet syndrome (DS).

The study duration will be up to approximately 62 weeks, including a 4-week screening/baseline period, a 52-week dose optimization treatment period (which includes a fixed 2-week titration period followed by flexible dose optimization), a 10-day taper period, and a safety follow-up period (4 weeks after the end-of-taper visit).

Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures

An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled Seizures

The CGIC/S is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores will be summed and the total will be reported. Higher scores indicate poor clinical outcome.

The Infant and Toddler Quality of Life Questionnaire Short Form 47 (ITQOL-47) was developed for use in infants and toddlers from 12-months-to-5 years of age and assesses levels of health and well-being. The caregiver will complete the assessment on an electronic device. For each concept, item responses are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health). Higher scores indicate better clinical outcome.

Treatment Responders are defined as participants with ≥ 50% reduction from baseline in caregiver-reported total countable seizures

This endpoint includes the following changes in percentage of seizures:

* \> 25% (increase);
* ≥ 0% to ≤ 25% (increase);
* \> -25% to \< 0% (reduction);
* \> -50% to ≤ -25% (reduction);
* \> -75% to ≤ -50% (reduction);
* ≤ -75% (reduction).

Jazz Pharmaceuticals

Ganglion Cysts

Drug Resistant Epilepsy

Synovial Cyst

Tin Fluorides

In either the MRI suite, or the Epilepsy Monitoring Unit, or the operating room, epilepsy and tumor subjects are asked to perform a variety of language-based tasks as neural recordings are made from and/or neural stimulations are delivered to various language areas of the brain.

Language-based tasks

Nitin Tandon, MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases	NCT00415376	Brain and Centr... Seizure Unspecified Adu...	levetiracetam quality-of-life...	18 Years -	Northwestern University
Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery	NCT05957822	Arthritis Knee Spine Fusion Prostate Cancer Arthritis of Hi... Hepatic Cancer	TXA TEG6	19 Years -	Konkuk University Medical Center
Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery	NCT05957822	Arthritis Knee Spine Fusion Prostate Cancer Arthritis of Hi... Hepatic Cancer	TXA TEG6	19 Years -	Konkuk University Medical Center
A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide	NCT01977651	Metastatic Cast...	Enzalutamide	-	Astellas Pharma Inc
Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors	NCT00629889	Brain and Centr... Seizure	levetiracetam pregabalin	18 Years -	Centre Hospitalier Universitaire Vaudois
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures	NCT04485104	Seizure in Part... Seizure in Part... Seizure in Part...	GWP42003-P	1 Month - 23 Months	Jazz Pharmaceuticals
The Neural Code and Dynamics of the Reading Network.	NCT05989893	Epilepsy Brain Tumor	Language-based ...	18 Years - 75 Years	The University of Texas Health Science Center, Houston
Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors	NCT00629889	Brain and Centr... Seizure	levetiracetam pregabalin	18 Years -	Centre Hospitalier Universitaire Vaudois
The Neural Code and Dynamics of the Reading Network.	NCT05989893	Epilepsy Brain Tumor	Language-based ...	18 Years - 75 Years	The University of Texas Health Science Center, Houston
1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients	NCT02334722	Brain Neoplasms Brain Cancer Brain Tumors Cancer of the B... Cancer of Brain Seizure	Levetiracetam	18 Years -	University of Florida

Spots Global Cancer Trial Database for seizure

Every month we try and update this database with for seizure 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 seizure

Every month we try and update this database with for seizure 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 seizure 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.