Massachusetts General Hospital

OverviewThe Neurological Clinical Research Institute (NCRI) was co-founded in 1994 by Dr. Merit Cudkowicz and Dr. Steven Greenberg to conduct clinical research in neurological disorders. The NCRI develops, designs, supports and manages innovative observational and interventional trials for neurological disorders.  In collaboration with the Study Monitoring and Outcome Measures Center at SUNY Upstate Medical Center and the Mass General Biostatistics Center, the NCRI has an impressive record of rapidly and efficiently organizing, overseeing, coordinating, and conducting small and large multi-center, international clinical trials including randomized, double-blind, double-dummy and open label designs.

The mission of the NCRI is to accelerate translational research in neurological disorders through initiating and testing novel therapies.  The NCRI will fulfill this mission by supporting the entire therapeutic development process, including:

· Mapping the clinical development of potential therapies;
· Custom design of clinical research protocols;
· Bringing efficiency strategies and infrastructure to clinical research;
· Providing resources, experienced staff, and services to accelerate the conduct of clinical research;
· Fostering and empowering scientific collaboration;
· Creating partnerships among scientific leaders with complementary backgrounds;
· Establishing and managing disease-specific research consortia;
· Performing high quality site-level clinical research;
· Educating and mentoring future leaders in the field of clinical research; and
· Encouraging scientific innovation through funding.

Northeast ALS Consortium (NEALS)

The NCRI serves as a Coordinating Center for the Northeast ALS Consortium (NEALS), a non-profit, research consortium committed to the cooperative implementation, timely completion, analysis, and reporting of clinical trials and other research studies aimed at improving patient care and understanding of the disease process of Amyotrophic Lateral Sclerosis (ALS). Together, the two entities have supported/conducted 19 clinical research studies in ALS.

Dr. Merit Cudkowicz co-founded and co-directs the NEALS Consortium. The NEALS Consortium was formed with the goal of bringing together leading ALS scientists and clinicians caring for ALS patients, to offer advice on the selection of the best therapies and direction of ALS research. Today there are 103 medical sites and more than 400 members across North America.

Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT)The NCRI serves as the Clinical Coordinating Center for the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), an National Institute of Neurological Disorders and Stroke (NINDS) initiative which provides a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations.   Today there are 25 sites nationally.

The Mass General Neurological Clinical Research Institute has over 60 staff members dedicated to neurology clinical research. 

Contact:

Merit Cudkowicz, MD, MSc
NCRI Co-Director
Massachusetts General Hospital
617-726-9122
mcudkowicz@partners.org

Steve Greenberg, MD, PhD
NCRI Co-Director
Massachusetts General Hospital
sgreenberg@partners.org

Nazem Atassi, MD
Massachusetts General Hospital
617-643-6114
natassi@partners.org

James Berry, MD
Massachusetts General Hospital
617-726-5097
jdberry@partners.org

Anne-Marie Wills, MD
Massachusetts General Hospital
617-726-9122
awills@partners.org

Patricia Andres, DPT, MS, PT
Massachusetts General Hospital
617-724-8995
pandres1@partners.org

Marianne Kearney
Director of Project Management
617-726-5893
mkearney4@Partners.org

Francine Murphy
Office/Program Manager
617-726-9122
fmurphy@partners.org

Darlene Sawicki, NP
Co-Director of MGH ALS Multidisciplinary Clinic
617-726-6190
dsawcki1@partners.org

Alex Sherman
Director of Systems
617-643-2935
avsherman@partners.org

Bryan Sweet
Director of Grants Management
617-724-3930
bsweet@partners.org

Hong Yu, MPH
Director of Data Management
617-726-5591
hyu2@partners.org

Our Work in ALS
Our staff is dedicated to finding new treatments for ALS. Our team leads and manages clinical trials at major medical institutions throughout the United States and Canada. The Mass General NCRI can also give interested individuals with ALS access to participate in clinical trials of medications and therapies designed to lead to better treatments. Below is a list of our active trials in ALS.

Active Trials in ALS

• Phase II/III Randomized, Placebo-controlled Trial of Arimoclomol in SOD1 Positive Familial Amyotrophic Lateral Sclerosis

• Clinical Trial of High Fat/High Calorie versus High Calorie versus Optimal Nutrition in Subjects with ALS

• Magnetic Resonance Spectroscopy in Amyotrophic Lateral Sclerosis (ALS)

• Stem Cells for Research in Motor Neuron Diseases (MND)

• A Multicenter Study for the Discovery and Validation of ALS

• Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis

• Analysis of Immune Activation in the Peripheral Blood of Patients with ALS

Other Work
The NCRI also serves as coordinating center for studies initiated by members of the Mass. General Neurology Department. It is the Data Management core for all NIH-funded MGH SPOTRIAS projects (Dr. Karen Furie, PI) as well as for a Parkinson’s disease biomarker study (Dr. Scherzer, PI). The MGH NCRI provides expertise in IND submissions and reporting, trial execution and feasibility and efficiency for various disease populations inclusive of studies in ALS, Multiple Sclerosis, Non-Arteritic Anterior Ischemic Optic Neuropathy, Progressive Supranuclear Palsy, Myasthenia Gravis, and Adrenoleukodystrophy.

Testing new drugs for ALS

Merit Cudkowicz, MD, director of the Mass General Neurological Clinical Research Institute, talks about clinical trials for Amyotrophic Lateral Sclerosis, also known as ALS, or Lou Gehrig's disease.

New ALS Gene Found

Investigators at Northwestern University School of Medicine have identified several gene mutations that may underlie most, if not all, cases of ALS.

Ceftriaxone, NP001, and Dexpramipexole Trials Close Enrollment

The phase III trial of Ceftriaxone; Neuraltus, the Phase II study of NP001 in ALS; and EMPOWER, the Phase III study of Dexpramipexole in ALS, are no longer recruiting participants.

The Northeast ALS Consortium (NEALS) Launches New Website

The Northeast ALS Consortium (NEALS) has launched their new website devoted to supporting clinical research of Amyotrophic Lateral Sclerosis (ALS) and other motor neuron disease (MND).

Results Announced for Phase I Trial of ISIS 333611 in SOD1 FALS

Results indicate that ISIS 333611 was well-tolerated.

US Brainstorm Trial Statement

Formal statement on the forthcoming US Brainstorm trial

Statement on the Clinical Trial of Ceftriaxone

The DSMB for the NINDS-sponsored clinical trial of ceftriaxone in ALS recommended that based on existing data the trial be stopped because the study was unlikely to reach the pre-determined efficacy criteria.

New neurology chief shares lessons

The 15th Annual Women in Medicine Month Celebration on Sept. 20 featured a keynote lecture by Merit Cudkowicz, MD, chief of Neurology.

Merit Cudkowicz to Hold Informational Webinar on the ALS Clinical Trial Pipeline

On Friday November 30th 2012, Merit Cudkowicz, MD, MSc, gave a webinar presentation for patients and their families. The archived webinar is now available for viewing.

Mass General/ Project A.L.S. Internship Program 2013

The Mass General / Project A.L.S. Internship Program at Massachusetts General Hospital in Boston offers students an exceptional opportunity to gain first-hand experience in the clinical research and care of ALS.

Mass General Hospital ALS Internship Program for College and Medical School Students 2013

The Mass General Hospital ALS Internship Program offers both college and medical school students an exceptional opportunity to gain first-hand experience in the clinical research and care of ALS.

Anne B. Young, MD, PhD, Fellowship in Therapeutic Development DEADLINE EXTENDED

Massachusetts General Hospital is pleased to announce that we are accepting applications for a joint MGH/Biogen Idec training program in translational neuroscience.

Massachusetts General Hospital Announces Neurological Clinical Research Institute

The Department of Neurology at Massachusetts General Hospital is pleased to announce that the Neurology Clinical Trials Unit has changed its name to the Neurological Clinical Research Institute (NCRI).

PRO-ACT: The Largest ALS Clinical Trials Database Ever Created

Open-access database will take researchers one step closer to finding a treatment and cure for ALS

NeuroNEXT Trial of SMA Biomarkers Enrolls First Participant

The Spinal Muscular Atrophy (SMA) Biomarkers Study is the first trial within the NeuroNEXT Network to enroll a participant

Webinar for ALS Patients and Families on Mexiletine in Sporadic ALS

Join us on Friday January 11th 2013 as Dr. Michael Weiss (University of Washington) will provide study rationale and background for Mexiletine in patients with sporadic ALS. He will also be available for Q&A.

Biogen Announces It Will Discontinue Development of Dexpramipexole Based on Phase 3 Trial Results

Biogen Idec has announced that the EMPOWER trial has failed to demonstrate efficacy in primary and secondary endpoints.

ALS Drug Development Gets FDA Hearing

PALS, caregivers, ALS advocates and researchers will gather on Monday February 25th to talk to the FDA about ALS, from the patient perspective.

Massachusetts General Hospital Researcher Receives Award for ALS Research

James D. Berry, MD, MPH has received the Richard Olney, MD, Clinician-Scientist Development Award for his investigation of cells in the immune system.

Phase II Clinical development of novel, high-potential treatments for people with ALS RFP

The Massachusetts General Hospital Neurological Clinical Research Institute (NCRI) and The ALS Assocation announce a call for Phase II clinical trial applications for novel, high potential treatments for ALS.

Neurological Clinical Research Institute (NCRI)

Phone: 617-643-3980
Email: mghneuroclinicaltrialsunit@partners.org

Public Transportation Access: yes
Disabled Access: yes

E-mail Address

General Inquiries: mghneuroclinicaltrialsunit@partners.org

E-mail Dr. Cudkowicz: mcudkowicz@partners.org

Mailing Address

Neurological Clinical Research Institute
Mailcode: CNY B149-2-2274
Massachusetts General Hospital
149 13^th Street, 2nd Floor, Room 2274
Charlestown, MA 02129

Clinical Research Staff

Marianne Kearney
Clinical Research Program/Project Manager
Phone: 617-726-5893
E-mail: MKearney4@Partners.org

Francine Murphy
Office/Program Manager
617-726-9122

Patient Appointments & Clinical Office

ALS Multidisciplinary Clinic
Phone: 617-724-3914