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29 result(s) found

Aneurysms


The Intra-arterial Vasospasm Trial - A Multicenter Randomized Study

The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration after cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome 90 days after patient discharge following in-hospital optimal intra-arterial drug treatment for cerebral vasospasm. This study is a prospective multicenter randomized trial.

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Brain Contusion


A Multicenter, Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients with Brain Contusion.

The primary objective of this study is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo. Secondary objectives and endpoints for the study are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.

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Glioblastoma


A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF-1R, in Newly Diagnosed Patients With Glioblastoma – The ImmuneSense Study

This is a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study, with the objective of comparing Progression-Free Survival (PFS) in newly diagnosed GBM patients treated with IGV-001 with patients treated with placebo.

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A Modified Ketogenic, Anti-Inflammatory Diet for Patients with High-Grade Gliomas

This is a phase I trial to see whether patients are able to adhere to a modified, high fat/low carbohydrate diet (the sHFLC + KetoPhyt Diet) with a supplement named KetoPhyt that includes ketones and anti-inflammatory properties.

The classic ketogenic diet (KD) is difficult for patients to adhere to due to its stringent nature. A modified KD has been developed that mimics the glucose lowering, ketone raising effects and the anti-cancer outcomes of the KD.

The sHFLC + KetoPhyt diet will be implemented in a cohort of 10 Glioblastoma patients, who will be trained and provided with sample meal plans so as to maintain their carbohydrate levels up to 33% of total caloric intake. The study will determine whether participants can maintain the diet and the ketogenic state.

This study will also conduct molecular analyses to determine the effect of the diet on the microbiome, inflammatory cytokines, and extracellular vesicle content.

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Glioblastoma Multiforme


CNS201: Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients with Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy

This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Approximately 210 patients with Glioblastoma Multiforme (GBM) after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of overall survival

In this research study, an investigational medication named berubicin is being compared to lomustine (an approved chemotherapy medication) for the treatment of recurrent GBM. 

The main purpose of this study is to investigate how effective berubicin is in treating GBM that has recurred after initial standard therapy, and comparing this with lomustine.  The study also aims to assess the safety of berubicin and how it is absorbed by and cleared from the body.  Both medications are designed to slow or stop the growth of cancer cells.

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Healthy Volunteers


Objective Portable Diagnostics of Neurological Disorders using Visual Evoked Potentials

This study focuses on developing a new portable noninvasive system to aid in the diagnosis of the vision disorders Multiple Sclerosis and Optic Neuritis. This device combines images and patterns using a Head Mounted Display, similar to a virtual reality headset. The system measures brain responses to these images using a form of electroencephalography (EEG), which will give us information about how the brain and eyes communicate and how this may be affected by a vision disorder.

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Intracerebral Hemorrhage


Statins Use In Intracerebral Hemorrhage Patients

SATURN is a multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE) clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation of statin therapy (using the same agent and dose that they were using at ICH onset). Participating subjects will undergo baseline testing for APOE genotype and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or major adverse cerebro-/cardio-vascular events (MACCE) during the follow-up period.

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Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.

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Statins Use in Intracerebral Hemorrhage Patients

SATURN is a multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE) clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation of statin therapy (using the same agent and dose that they were using at ICH onset). Participating subjects will undergo baseline testing for APOE genotype and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or major adverse cerebro-/cardio-vascular events (MACCE) during the follow-up period

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Intracranial Pressure


Prospective evaluation of non-invasive intracranial pressure monitoring

Patients who are admitted to the Tufts Medical Center ICU or PICU and are deemed to require placement of an intracranial pressure (ICP) monitor will be asked to enroll in our study. Patients agreeing will undergo the routine placement of an ICP monitor followed by placement of the study device; a non-invasive extracranial device (I PASS - Intracranial Pressure Assessment and Screening System, Vivonics, INC) containing near infrared probes placed on the ear, forehead and finger. The data will be recorded from IPASS as the routine ICP is recorded. Patients vital signs including heart rate, blood pressure, and SpO2 will also be routinely recorded. Once the patient is felt to no longer require the ICP monitor and it is removed, the IPASS device will also be removed.

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Migraine


preventive TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems

The purpose of this study is to collect information about treatment patterns, effects, and outcomes in patients with migraines who are switching or initiating a pharmacologic treatment for migraine prevention. This is an observational study which means there will be no treatment added or taken away.

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Multiple Sclerosis


A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis

The purpose of the study is to assess the efficacy and safety of SAR442168 compared with teriflunomide (Aubagio) in participants with relapsing multiple sclerosis (RMS).

The experimental drug works in the blood and in the brain where it blocks a molecule called “Bruton's tyrosine kinase (BTK)”, which is present in some cells involved in multiple sclerosis (immune cells known as B-cells and microglial cells). This mechanism of action may help stop the formation of new brain lesions in MS.

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A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis

The purpose of the study is to see if the study drug, SAR442168, works to delay the progression of disability in people with NRSPMS compared to placebo and has an acceptable safety profile.

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A Phase 3, Randomized, Double-Blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants with Primary Progressive Multiple Sclerosis

The purpose of the study is to see if the study drug, SAR442168, works to delay the progression of disability in people with PPMS compared to placebo and has an acceptable safety profile.

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Objective Portable Diagnostics of Neurological Disorders using Visual Evoked Potentials

This study focuses on developing a new portable noninvasive system to aid in the diagnosis of the vision disorders Multiple Sclerosis and Optic Neuritis. This device combines images and patterns using a Head Mounted Display, similar to a virtual reality headset. The system measures brain responses to these images using a form of electroencephalography (EEG), which will give us information about how the brain and eyes communicate and how this may be affected by a vision disorder.

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Myasthenia Gravis


A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis

This is a phase 3, randomized, double-blind, placebo-controlled, multicenter study that evaluates using ravulizumab infusions as treatment for patients with generalized Myasthenia Gravis. Participants will receive either ravulizumab for the duration of the study or placebo during the 26-week randomized-controlled period of the stufy and then enter the open-label extension period where they will receive ravulizumab. The main outcome will look at the change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at week 26 (end of randomized period).

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Neurologic Diseases


Developing an activity-dependent marker of upper motor neuron dysfunction in motor neuron disorders.

This study is evaluating the potential to use transcranial magnetic stimulation in diagnosis of diagnosis of neurologic conditions that effect movement. We are seeking healthy volunteers and participants with a neurologic condition that affects the ability to move parts of your body.

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Optic Neuritis


Objective Portable Diagnostics of Neurological Disorders using Visual Evoked Potentials

This study focuses on developing a new portable noninvasive system to aid in the diagnosis of the vision disorders Multiple Sclerosis and Optic Neuritis. This device combines images and patterns using a Head Mounted Display, similar to a virtual reality headset. The system measures brain responses to these images using a form of electroencephalography (EEG), which will give us information about how the brain and eyes communicate and how this may be affected by a vision disorder.

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Spine Injuries and Disorders


A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury

The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve function in patients with acute traumatic cervical spinal cord injury (SCI).  

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Status Epilepticus


A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous Ganaxolone in status epilepticus

Status Epilepticus(SE) is a serious condition that needs fast treatment to stop the seizures and prevent permanent brain damage. The purpose of this research is to find out if ganaxolone can stop or decrease the seizure activity in participants who have SE and if ganaxolone is safe compared to placebo when given to participants who are on other anti-seizure medications.

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Stroke


A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke

The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve cognitive and/or motor functioning in an individual following the occurrence of acute ischemic stroke. This is a 52-week, Phase 2a, randomized, double-blind, parallel-group, placebo-controlled, multicenter proof-of concept study.

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Driving Ability Tests for Cognitive and Sensorimotor Function Assessment

The purpose of this research is to enhance and support our understanding and evaluating actual response behaviors of cognitive disability in realistic tasks. We hope to obtain more information about the response behaviors to stimuli during simulated driving of a typical cohort compared to post-stroke cohorts.

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Prospective randomized multi-center controlled clinical investigation comparing PFO outcomes of the Occlutech Flex II PFO Occluder to standard of care PFO occlusion.

The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE)

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Sleep for Stroke Management And Recovery Trial

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

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AMPLATZER PFO Occluder Post Approval Study (PFO PAS)

Abbott developed the AMPLATZER™  PFO Occluder as a minimally invasive, transcatheter PFO closure treatment to further reduce the risk of recurrent stroke among patients with PFO and cryptogenic stroke beyond that achieved with medical management. This additional risk reduction is achieved by blocking the pathway for a venous embolism from reaching the body's arterial system and the brain. 

The safety and effectiveness of the AMPLATZER PFO Occluder was evaluated in RESPECT, a randomized controlled clinical trial conducted under an investigational device exemption (IDE), which was the largest trial of a transcatheter PFO closure device, with the longest follow-up. RESPECT demonstrated that the AMPLATZER PFO Occluder is effective in reducing recurrent ischemic stroke in subjects implanted with the device and can be implanted safely. The AMPLATZER PFO Occluder received market approval by FDA on October 28, 2016.

The purpose of this study is the continued evaluation of the long-term safety and effectiveness of the AMPLATZER PFO Occluder in a post approval setting. 

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AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke

ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NIH StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.

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Stroke and Young Adults: A qualitative assessment of the hospitalization for acute stroke, shared decision-making, and perception of risk

The purpose of this research study is to explore the challenges of recognizing stroke in young adults, the process of making treatment decisions, and the patient’s understanding of the risk of recurrence and long term consequences of stroke. This study consists of a 30 to 60 minute interview of patients with prior stroke (ischemic stroke, transient ischemic attack, or intracerebral hemorrhage) who were 18-50 years of age at the time of stroke onset.

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Subarachnoid Hemorrhage


The Intra-arterial Vasospasm Trial - A Multicenter Randomized Study

The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration after cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome 90 days after patient discharge following in-hospital optimal intra-arterial drug treatment for cerebral vasospasm. This study is a prospective multicenter randomized trial.

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Tremor


A Multi-center, Noninterventional Study Evaluating Variability, Reliability, and Compliance for the Parkinson's Disease Diary

This is a global, multi-center, noninterventional study that will collect data on patients with PD under standard-of-care treatment according to local routine clinical practice. The primary objective of the study is to assess the impact of the frequency of assessments on the variability over time, reliability, and compliance for the PD diary in patients with PD in whom medications do not provide adequate control of symptoms. The secondary objectives of the study are to document changes in motor function as a measure of disease progression and characterize the stability or rates of change on motor function, quality of life, and use of standard PD medications in patients with PD in whom medications do not provide adequate control of symptoms.

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