Neurology &
Neurological Sciences
Neurology & Neurological Sciences Clinical Trials

Neurology & Neurological Sciences Clinical Trials

Neurology

A Phase I/II Study of Local Field Irradiation and Temozolomide Followed by Continuous Infusion Plerixafor as an Upfront Therapy for Newly Diagnosed Glioblastoma GBM 
PI: Lawrence Recht, MD (NCT01977677)

ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
A prospective, randomized, double-blind crossover, multi-site, two-arm study will test the efficacy of treatment using the ExAblate Transcranial System and demonstrate safety in medication-refractory tremor in subjects with essential tremor.
PI: Pejman Ghanouni, MD, PhD (NCT01827904)

A Feasibility Study to Evaluate the Safety and Initial Effectiveness of MR Guided High Intensity Focused Ultrasound (MRgHIFU) in the Treatment of Facetogenic Lumbar Back Pain
To evaluate the safety and initial effectiveness of using MR guided focused ultrasound technology to treat low back pain caused by facet joint arthritis.
PI: Pejman Ghanouni, MD, PhD

Alzheimer's Disease Neuroimaging Initiative 2 (ADNI2)
This study will build upon the Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD) with neuroimaging.
PI: Jerome Yesavage, MD (NCT01231971)

A Study to Explore the Safety and Tolerability of Acthar in Patients with Amyotrophic Lateral Sclerosis
An 8-week randomized, open-label evaluation to examine the acute safety and tolerability of 4 Acthar dosing regimens to inform dose selection for future studies of Acthar in patients with Amyotrophic Lateral Sclerosis.
PI: Yuen So, MD, PhD (NCT01906658)

Compassion Training and Pain
The purpose of this study is to determine whether compassion training will improve the physical and psychological well-being of patients with chronic pain.
PI: Sean Mackey, MD, PhD (NCT01776645)

Epilepsy Impact Scale
The investigators are developing a questionnaire to quickly measure the impact of epilepsy on a person's life and whether it increases, decreases or stays the same over time.
PI: Robert Fisher, MD, PhD (NCT01833234)

Maternal and Neurodevelopmental Outcomes of in Utero Antiepileptic Drug (AED) Exposure (MONEAD)
To establish the relationship between antiepileptic drug exposure and outcomes in the mother and child as well as describe and explain the variability in antiepileptic drug exposure and response
PI: Kimford J. Meador, MD (NCT01730170)

VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)
Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage 2) of the Model 106 VNS implantable pulse generator.
PI: Robert Fisher, MD, PhD (NCT01846741)

Lactic Acidosis During and After Seizures
This project looks at the time course of lactic acid rise (if any) after seizures. Salivary and capillary lactic acids are tested.
PI: Robert Fisher, MD, PhD (NCT01833247)

Analysis of Cytokine Modulation with Tecfidera in Human Immune Cell Subsets Using High Dimensional Flow Cytometry and CYTOF Mass Spectrometry
Eprotocol number 29046
This is an open label longitudinal study analyzing peripheral blood lymphocyte subsets in patients with Relapsing Remitting Multiple Scleorsis (RRMS) that are on Tecfidera.
PI: Lawrence Steinman
Actively enrolling

Blood, CSF and Tissue Repository To Identify Biomarkers in Multiple Sclerosis
Stanford Protocol #16691
Sponsor: Stanford University
PI: May Han, MD
Study Active, Enrollment Open

A Randomized Controlled Trial of Vitamin D in Multiple Sclerosis
NCT01490502
Sponsor: Johns Hopkins University, National MS Society
PI: Jeffrey Dunn, MD
closed to enrollment, closed to study activities

Multicenter, Randomized, Double-Blind, Parallel-Group Extension to Study AC-058B201 to Investigate the Long-Term Safety, Tolerability, and Efficacy of 10, 20, and 40 mg/day ACT-128800, an Oral S1P1 Receptor Agonist, in Patients with Relapsing-Remitting Multiple Sclerosis
NCT01093326
AC-058B202
Sponsor: Actelion Pharmaceuticals Ltd
PI: Jeffrey Dunn, MD
Study Active, Enrollment Closed

A Randomized, Double-blind, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif ®) in Patients with Relapsing Multiple Sclerosis
NCT01412333
WA21093
Sponsor: Genentech
PI: Jeffrey Dunn, MD
Study is closed to enrollment, Open Label Extension is ongoing

A Double-Blind, Placebo-Controlled, Single Ascending Intravenous Infusion Study of rHIgM22 in Patients with Multiple Sclerosis              
NCT01803867
IM22-MS-1004
Sponsor: Acorda
PI: Jeffrey Dunn, MD
Study Active, Enrollment Closed

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex
NCT01864148
215MS201
Sponsor: Biogen Idec
PI: Viet Nguyen, MD
Study Active, Enrollment Closed

Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II)
To 1) determine the therapeutic benefit of intensive treatment compared to standard treatment in patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset; 2) compare quality of life at 3 months;  3) compare hematoma expansion;  and 4) compare treatment-related serious adverse events within 72hrs.
PI: Chitra Venkatasubramanian, MBBS, MD (NCT01176565)

Development of Multimodal Imaging Biomarkers for Cognitive Dysfunction in Parkinson's Disease
To develop multimodal imaging biomarkers to characterize the etiology of Parkinson's disease associated cognitive impairment and dementia.
PI: Kathleen Poston, MD, MS

Early Differential Diagnosis of Parkinsonism with Metabolic Imaging and Pattern Analysis
PI: Kathleen Poston, MD, MS

A Phase II, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention
To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days, in subjects with chronic migraine.
PI: Sheena K. Aurora, MD (NCT02066415)

CHAMP: The Childhood and Adolescent Migraine Prevention Study
To evaluate if amitriptyline (AMI) and topiramate (TPM) are superior to placebo in reducing migraine frequency in children and adolescents, ages 8 to 17 years old, inclusive, and to conduct a comparative effectiveness study of the two therapies.
PI: Sheena K. Aurora, MD (NCT01581281)

Non-Invasive Neurostimulation of the Vagus Nerve with the Gammacore Device for the Treatment of Cluster Headache
To collect clinical data related to the safety and effectiveness of non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of cluster headache.
PI: Sheena K. Aurora, MD (NCT01792817)

Assessment of LBR-101 in Chronic Migraine
To evaluate the efficacy of two distinct doses of subcutaneous LBR-101 in the preventive treatment of chronic migraine, measured by mean change from baseline in number of monthly cumulative headache hours of any severity on headache days, captured from the daily headache diary, relative to the 28-day post treatment period ending with week 12.
PI: Sheena K. Aurora, MD (NCT02021773)

A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine (HFEM)
To evaluate the efficacy of two distinct doses of subcutaneous LBR-101 in the preventive treatment of HFEM, measured by mean change from baseline in the monthly migraine days during the 28-day post treatment period ending with week 12.
PI: Sheena K. Aurora, MD (NCT02025556)

Migraine Prophylaxis with BOTOX in Adults
To study the long-term efficacy, safety and tolerability of BOTOX (onabotulinumtoxinA) for the prophylaxis of headaches in adult patients with chronic migraine
PI: Meredith Barad, MD

Migraine Prophylaxis with BOTOX in Children
To study the long-term efficacy, safety and tolerability of BOTOX (onabotulinumtoxinA) for the prophylaxis of headaches in adolescents patients (children 12 to < 18 years of age) with chronic migraine.
PI: Meredith Barad, MD

Screening Tool Validation for Chronic Migraine
PI: Nada Hindiyeh, MD

Population-based Studies of the Prevalence and Predisposing Factors of Peripheral Neuropathy
In collaboration with epidemiologists at UC Berkeley, the study investigates the potential environmental or occupational risk factors for peripheral neuropathy.
PI: Yuen So, MD, PhD

HDE Post-Approval Study (PAS) of NeuRx DPS™ for ALS 
Further investigation on the benefits and risks of diaphragmatic pacing to preserve respiratory function in patients with amyotrophic lateral sclerosis (ALS).
PI: Yuen So, MD, PhD (NCT01605006)

A Phase IV Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease
PI: John Day, MD, PhD (NCT01526785)

Brain Networks in Neurodegenerative Diseases
To prospectively evaluate the application of FDG PET to aid in the diagnosis of Parkinson’s disease and other atypical Parkinsonian syndromes. 
PI: Kathleen Poston, MD, MS

Transient Ischemic Attack (TIA) Triage and Evaluation of Stroke Risk
PI: Gregory Albers, MD (NCT01423201)

An Exploratory Study to Assess Two Doses of GSK2402968 in the Treatment of Ambulant Boys with Duchenne Muscular Dystrophy
PI: Yuen So, MD, PhD (NCT01462292)

The PLasma for Alzheimer's SymptoM Amelioration (PLASMA) Study
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Intravenously Administered Plasma from Young Donors for Treatment of Mild-to-Moderate Alzheimer's Disease
PI: Sharon J. Sha, MD MS (NCT02256306)
                                               
Efficacy and Safety Trial of MK-8931 in Participants with Prodromal Alzheimer's Disease
A Phase III, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Clinical Trial to Study the Efficacy and Safety of MK-8931 in Subjects with Amnestic Mild Cognitive Impairment Due to Alzheimer’s Disease.
PI: Sharon J. Sha, MD MS (NCT01953601)

The Aging Brain: Risk for Dementia
This study will enroll older individuals with cognitive problems with the goal of determining which factors are most predictive developing dementia. 
PI: Sharon J. Sha, MD MS

Tissue Banking of Blood, Spinal Fluid or Skin Biopsy for the Research of Neurological Diseases
PI: Yuen So, MD, PhD

Clinical and Genetic Characterization of Myotonic Dystrophy
PI: John W. Day, MD, PhD

Safety and Efficacy Evaluation of Threshold Sound Conditioning by Conditioning-enhanced
Hearing Aid
PI: Jaime Lopez, MD

A Phase III, Randomized, Open-Label, 500-Subject Clinical Trial of Minimally Invasive Surgery Plus rt-PA in the Treatment of Intracerebral Hemorrhage (MISTIE III)   
PI: Chitra Venkatasubramanian, MBBS, MD (NCT01827046)

Subject Database and Specimen Repository for Neuromuscular and Neurodegenerative Disorders
PI:  John W. Day, MD, PhD

Inherited Neuropathies Consortium
PI: John W. Day, MD, PhD

Development and Validation of a Disability Severity Index for Charcot-Marie-Tooth Disease
PI: John W. Day, MD, PhD (NCT01455623)

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ISIS 396443 Delivered Intrathecally to Patients with Infantile-Onset Spinal Muscular Atrophy
PI: John W. Day, MD, PhD (NCT01839656)

A Phase III Efficacy and Safety Study of Ataluren (PTC124) in Patients with Nonsense Mutation Dystrophinopathy
PI: John W. Day, MD, PhD (NCT01826487)

Phase I/Ib, Multicenter, Open-label, Dose-Escalation and Expansion Study to Evaluate the Safety and Antitumor Activity of MEDI3617, a Human Monoclonal Antibody Directed Against ANG2, as a Single-Agent or in Combination Therapy in Adult Subjects with Advanced Solid Tumors.
PIs: Seema Nagpal, MD and Lawrence Recht, MD (NCT01248949)

Stanford Stroke Center Clinical Trials

iDEF - Futility Study of Deferoxamine Mesylate in Intracerebral Hemorrhage; A prospective, multi-center, double-blind, randomized, placebo-controlled, phase-II clinical trial.
The purpose of this study is to determine whether treating patients with a type of bleeding in the brain (intracerebral hemorrhage; ICH) with a drug called deferoxamine mesylate could be helpful in recovery after ICH. NCT02175225
PI: Chitra Venkatasubramanian, MBBS, MD
STATUS: RECRUITING

MISTIE III: A Phase III, Randomized, Open-Label, 500-Subject Clinical Trial of Minimally Invasive Surgery Plus rt-PA in the Treatment of Intracerebral Hemorrhage
The study will evaluate the efficacy and safety of Minimally Invasive Surgery plus 1 mg of rt-PA administered every eight hours for up to nine doses as compared to subjects treated with conventional medical management. NCT01827046
PI: Chitra Venkatasubramanian, MBBS, MD
STATUS: RECRUITING

SOCRATES –Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patient OutcomES
The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor vs aspirin for the prevention of major vascular events (composite of stroke, myocardial infarction [MI], and death) in patients with acute ischemic stroke or transient ischemic attack (TIA). NCT01994720
PI: Waimei Amy Tai, MD
STATUS: RECRUITING

Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals (GAMES-RP) Study
The purpose of this trial is to demonstrate the efficacy of RP-1127 (Glyburide for Injection) compared to placebo in subjects with a severe anterior circulation ischemic stroke who are likely to develop malignant edema.
Protocol ID: 26458, NCT01794182
Protocol Title: PI: Gregory Albers, MD
STATUS: RECRUITING

Protocol ID: 20543, NCT01176565
Protocol Title: Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II: A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage
The purpose of this trial is to determine the therapeutic benefit of the intensive systolic
blood pressure (SBP)treatment compared with standard SBP treatment for 24 hours
after randomization in reducing the proportion of patients with death and disability at
90 days among subjects with intracerebral hemorrhage
PI: Chitra Venkatasubramaian, MD
STATUS: RECRUITING

Advanced MR and CT Imaging for Understanding Acute Stroke Evolution and Predicting Response to Recanalization Therapy (SENSE 3) Protocol ID: 27214
This project aims to compare for the first time the diagnostic ability of CT and MR to reliably identify irreversibly damaged tissue, at-risk (but potentially salvageable) tissue, and the “leakiness” of injured vessels in acute stroke patients.
PI: Roland Bammer, PhD
STATUS: RECRUITING

Imaging Collaterals in Acute Stroke (iCAS)
NCT02225730
The overall goal of the imaging the Collaterals in Acute Stroke (iCAS) study, is to identify and quantify cerebral blood flow (CBF) delivered via collateral routes using arterial spin labeling (ASL), a non-contrast MRI technique, and to determine its impact on ischemic lesion growth and patient outcome.
PI: Gregory Zaharchuk, MD
STATUS: RECRUITING

Evaluation of Cerebral Edema in Acute Ischemic and Hemorrhagic Stroke Using Volumetric Integral Phase-shift Spectroscopy (VIPS):  a Pilot Study.
The Cerebrotech Intracranial Fluid monitor (VIPS) is a new non-invasive device that uses very low levels of radio waves to look at brain swelling. The purpose of this study is to see if the Cerebrotech monitor can measure values in patients with ischemic stroke and to see if these values correlate with other ways that are currently used to measure brain swelling (such as repeated CT scans).
PI: Karen Hirsch, MD
STATUS: RECRUITING

Protocol ID: 18552, NCT00991029
Protocol Title: Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial, a Randomized, Double-blind, Multicenter Clinical Trial
The primary aim of this trial is to determine whether clopidogrel 75 mg/day by mouth is effective in reducing the 90-day risk of major ischemic vascular events.
PI: Gregory Albers, MD/James Quinn, MD
STATUS: RECRUITING

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial Protocol ID: 23077, NCT01369069
This is a Phase III multicenter, randomized and controlled clinical trial of 1400 patients within 12 hours of stroke symptom onset, with diabetes and glucose concentrations of over 110 mg/dL on initial evaluation to determine if treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke.
PI: James Quinn, MD
STATUS: RECRUITING

SCAN--Comprehensive Stroke Recovery Study
The SCAN study brings together neuroscientists, engineers, and clinical researchers to elucidate the mechanisms that underlie successful stroke recovery. In the future, this knowledge will help to develop treatments to enhance recovery from stroke. This study aims to develop tools to better understand functional recovery and the mechanisms that underlie stroke recovery through the following assessments:  1) cognitive testing, 2) functional assessments, 3) MRI, 4) TMS/EEG and 5) blood sampling. Participants are assessed at baseline (<2 months post-stroke), 30 days, 90 days, 6 months, and 1 year.
PI: Marion Buckwalter MD, PhD; Maarten Lansberg,  MD, PhD
STATUS: RECRUITING

The Insulin Resistance Intervention after Stroke Trial (IRIS)
To determine if pioglitazone, compared to placebo, will reduce the overall risk for fatal or nonfatal stroke or fatal or non-fatal MI among non-diabetic men and women over age 44 years with insulin resistance and a recent ischemic stroke or TIA.
NCT00091949
PI: Lansberg
STATUS: ENROLLMENT CLOSED

CT Perfusion to Predict Response to Recanalization in Ischemic Stroke Project (CRISP)
Protocol ID: 22227, NCT01622517
The goal of this project is to obtain sufficient preliminary data to optimally design a definitive study to assess the risks and benefits of new stroke treatments aimed at restoration of blood flow.
PI: Maarten Lansberg, MD, PhD
STATUS: ENROLLMENT CLOSED

TIA Triage Study
Protocol ID: 19211, NCT01423201
Protocol Title:
PI: Gregory Albers, MD

Thrombolysis in Pediatric Stroke (TIPS)
Protocol ID: 24562, NCT01591096
PI: Jorina Elbers, MD
STATUS: ENROLLMENT CLOSED

Prognostic Value of MRI and Biomarkers in Comatose Post-Cardiac Arrest Patients
This study is designed to assess the value of state-of-the art brain imaging techniques (MRI), and blood tests in predicting outcome in patients after cardiac arrest.
Protocol ID: 14447
Protocol Title: PI: Karen Hirsch, MD
STATUS: ENROLLMENT CLOSED

Microvascular Measures of Perfusion in Stroke Recanalization (PERFUSE 2)
The overall goal of this project is to identify and improve cerebral blood flow (CBF) techniques from dynamic susceptibility contrast (DSC) perfusion-weighted MRI (PWI) methods that can depict both restoration of flow together with the microvascular status that would optimally compare with DWI to form a clinically useful DWI-PWI mismatch representing brain tissue-at-risk or salvageable brain.
Protocol ID: 16416
PI: Michael Moseley, MD, PhD
STATUS: ENROLLMENT CLOSED

CLEAR III Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
The goal of this project is to determine whether EVD placement with low-dose rt-PA improves modified Rankin Scale scores at 6 months (dichotomized Rankin 0-3 vs. 4-6) compared to subjects treated with EVD placement with placebo (normal saline).
Protocol ID: 15585, NCT00784134
PI: Chitra Venkatasubramaian, MD
STATUS: ENROLLMENT CLOSED

Prognosis of Critically Ill Neurological Patients (PROGNOSIS)
Protocol ID: 14058
PI: Anna Finley Caulfield, MD
STATUS: ENROLLMENT CLOSED

Protocol ID: NCT00822900
Protocol Title: Progesterone for the Treatment of Traumatic Brain Injury (ProTECT III)
PI: James Quinn, MD
STATUS: CLOSED

PEDIATRIC NEUROLOGY

Phase III Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy 18.00 Gy and Chemotherapy in Children with Newly Diagnosed Standard Risk Medulloblastoma
PI: Paul Fisher, MD (NCT00085735)

Efficacy of Carboplatin Administered Concomitantly with Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other than Average Risk Medulloblastoma/PNET Patients 
PI: Paul Fisher, MD (NCT00392327)

Phase II Screening Trial of Temozolomide with Irinotecan versus Temozolomide, Irinotecan plus for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood
PI: Paul Fisher, MD (NCT01217437)

A Randomized Phase II/III Study of Vorinostat and Local Irradiation OR Temozolomide and Local Irradiation OR Bevacizumab and Local Irradiation Followed by Maintenance Bevacizumab and Temozolomide in Newly Diagnosed High Grade Glioma
PI: Paul Fisher, MD (NCT01236560)

Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years
PI: Paul Fisher, MD (NCT01096368)

A Phase II Study of Sunitinib in Recurrent, Refractory or Progressive High Grade Glioma and Ependymoma Brain Tumors in Pediatric and Young Adult Patients
 PI: Paul Fisher, MD (NCT01462695)

A Phase II Randomized Trial of Lenalidomide (NSC # 703813, IND # 70116) in Pediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytoma and Optic Pathway Gliomas
 PI: Paul Fisher, MD (NCT01553149)

Phase II Trial of Response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS GCT)
PI: Paul Fisher, MD (NCT01602666)

Risk-Adapted Therapy for Young Children with Embryonal Brain Tumors, High-Grade Glioma, Choroid Plexus Carcinoma Or Ependymoma (SJYC07)
PI: Paul Fisher, MD (NCT00602667)

Phase I and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma
PI: Paul Fisher, MD (NCT01089101)

Phase II Clinical Trial Evaluating the Efficacy and Safety of GDC-0449 in Children with Recurrent or Refractory Medulloblastoma
PI: Paul Fisher, MD (NCT01239316)

Comprehensive Molecular Analysis of Tumor Samples Derived From Patients with Diffuse Brainstem Glioma—A Pilot Study
PI: Paul Fisher, MD (NCT00899834)

A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor
PI: Paul Fisher, MD (NCT01381718)

A Molecular Biology and Phase II Study of Imetelstat (GRN163L) in Children with Recurrent High-Grade Glioma, Ependymoma, Medulloblastoma/Primitive Neuroectodermal Tumor (PNET) and Diffuse Intrinsic Pontine Glioma (DIPG)
PI: Paul Fisher, MD (NCT01836549)


For questions about the following clinical trials please contact our clinical trials research coordinator Maria Coburn at 650-736-9551 or mcoburn@stanford.edu


For more details on all of our clinical trials visit the SOM Clinical Trial Database or visit ClinicalTrials.gov

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