Welcome.
NEALS Continues to Grow
December 14, 2007
NEALS membership has grown to seventy-one members. Our newest member is:
- University of Nevada (Henderson, NV)--David L. Ginsburg, MD, site principal investigator
Complete contact information for this site is located on the Contacts page under NEALS Clinical Centers.
We look forward to future collaboration with our new member. Welcome!
NEALS Meeting at 18th International Symposium on ALS/MND
Sunday, December 2, 2007
A NEALS meeting is planned to take place during the 18th Int'l Symposium on ALS/MND in Toronto, Canada. The meeting is scheduled for Sunday, December 2nd at 7:00-8:30AM in Queens Quay.
Please email your RSVP by November 15th to jetellier@partners.org, or by phone at 617-724-7398.
7th Annual NEALS Meeting-Fall 2008
The 7th Annual NEALS meeting is scheduled to take place at the Hyatt Regency, Cambridge, MA, on October 2 & 3, 2008 (Thursday & Friday).
Meeting information and registration will be available during the Summer 2008.
NEALS receives funding from ALS Association!
June 25, 2007
NEALS has been awarded funding through the ALS Association’s (ALSA) Translational Research Advancing Therapy for ALS (TREAT ALS) initiative to form the TREAT ALS/NEALS Clinical Trials Network. The funding will support training of clinical trial sites and investigators and further development of the NEALS Electronic Data Capture and Clinical Trials Management system (PharmaENGINE).
The goal of TREAT ALS is the same as the mission of the NEALS Consortium, “To translate research advances rapidly into clinical trials for patients with ALS.” The TREAT ALS initiative recognizes the importance and strengths of the NEALS Consortium. This new collaboration will help bring access to new therapies to people with ALS throughout the United States.
NEALS Office Closings through December 31, 2007
Monday, February 19th (President's Day)
Monday, May 28th (Memorial Day)
Wednesday, July 4th (Independence Day)
Monday, September 3rd (Labor Day)
Monday, October 8th (Columbus Day)
Thursday, November 22nd (Thanksgiving)
Tuesday, December 25th (Christmas)
2008 NEALS Office Closings
Tuesday, January 1st (New Year's Day)
Monday, January 21st (Martin Luther King Day)
Monday, February 18th (President's Day)
Monday, May 26th (Memorial Day)
Friday, July 4th (Independence Day)
Monday, September 1st (Labor Day)
Monday, October 13th (Columbus Day)
Thursday, November 27th (Thanksgiving Day)
Thursday, December 25th (Christmas Day)
Enrollment Begins in Arimoclomol Phase IIb Study
December 21, 2007
The Phase 2b clinical trial of arimoclomol has begun. CytRx Corp. expects to enroll approximately 390 ALS patients from 30 – 40 clinical centers in the U.S. and Canada. This study will evaluate the safety and efficacy of 400mg arimoclomol administered orally three times daily for a nine month period.
Interested patients, Investigators and Coordinators may call the Neurology Clinical Trials Unit at Massachusetts General Hospital at 1-877-458-0631.
NEALS Trial of Ceftriaxone in ALS Begins Enrollment
May 18, 2007
The Ceftriaxone Clinical Trial has officially begun! The study enrolled the first subject on August 10, 2006. Ceftriaxone is an antibiotic (in a class known as “cephalosporins”) that is approved by the FDA to treat certain types of infections. The investigators involved in this study are interested in studying ceftriaxone because the drug may also increase the level of a protein that decreases glutamate levels near nerves. Studies of ceftriaxone in the laboratory suggest that it may protect motor neurons from injury.
The study will treat up to 600 research participants with ALS enrolled at 40-50 centers in the US and Canada using a three-step sequential drug development design. The study is currently more than halfway to the enrollment goal for the first step. The investigators anticipate that the next stage of the study will start in late 2007.
STUDY DETAILS:
This research study will be done in stages. The first stage will seek to determine whether ceftriaxone enters the cerebrospinal fluid (CSF, the fluid that surrounds the spinal cord) in amounts that are high enough to be of possible benefit. The second stage will look at the safety and side effects of the study drug when taken daily for 16 weeks. The third stage will try to find out whether the study drug helps people with ALS live longer. This is a double-blind, placebo-controlled study. This means that neither participants nor investigators will know who is receiving ceftriaxone and who is not; and that a portion of the study participants will receive ceftriaxone, while another portion receive a placebo (an inert substance that looks like ceftriaxone). Because ceftriaxone is in intravenous (IV) medication, participants will also have a catheter (called a central venous catheter or "Hickman" catheter) placed, which will remain in place for the duration of the study and through which the study medication will be given.
STUDY VISITS:
Study visits are approximately every 4 weeks, and are more frequent the first month. This is a long-term study, so participants may be in the study for anywhere from one to five years. Participants will have safety laboratory tests throughout the study and their strength and vital capacity will be tested at regular intervals.
CONTACT INFORMATION:
If you would like more information, or if you are interested in participating in this study, please contact the Coordination Center at Massachusetts General Hospital at (617) 643-3980 or fmurphy@partners.org
Click here to read more (NEALS Clinical Trials: Planning Stages).
Results of the Celebrex Trial to Appear in Annals of Neurology
July 2006
The paper reporting the results from NEALS Celebrex trial, (titled "Trial of Celecoxib in Amytrophic Lateral Sclerosis) has been published in Annals of Neurology.
We would like to thank all of the research participants, the sites and their staff, and everybody who helped run this trial effectively. It was an excellent team.
Enrollment Complete for the Phase IIa Study of Arimoclomol in ALS
April 10, 2006
The NEALS Consortium Phase IIa study of arimoclomol in ALS has completed its enrollment goal of 84 participants at 10 NEALS centers. The study began enrolling in October 2005, and is the fastest-enrolling study that NEALS has conducted to date.
Proteomic/Metabolomic Study Identifies 35 Biomarkers for ALS
April 6, 2006
Metabolon, Inc., a biotech company specializing in metabolomic analysis, recently completed a study of biomarkers in ALS, in collaboration with three NEALS Consortium centers: the University of Pittsburgh School of Medicine, the Massachusetts General Hospital Neurology Clinical Trials Unit, and the Duke University Medical Center. Several members of the NEALS Coordinating Center also worked on the study. The goal of the study was to identify protein and/or metabolite biomarkers that are altered in ALS, in order to better understand the mechanisms of the disease and, more importantly, to develop a diagnostic method that is rapid and accurate. The study revealed almost three dozen biomarkers for ALS, a discovery of tremendous value.
The study analyzed cerebrospinal fluid (CSF) samples from 40 healthy controls and 106 ALS patients. The metabolites in the samples were measured, then compared to a library of known metabolic signatures. The proteomic profiles of the two groups were compared using the technology of surface-enhanced laser desorption/ionization-time of flight mass spectrometry (SELDI-TOF-MS). The analyses identified 16 metabolic biomarkers and 19 protein biomarkers that were different in the ALS group. The researchers validated the predictive value of the biomarkers using 44 ALS and 25 control samples. The biomarkers panel will undergo additional testing in patients in the early stage of the disease.
The development of a biomarker panel is certain to have a profound impact on all aspects of ALS research. The abstract of this landmark study was highlighted at this year's American Academy of Neurology annual conference, which took place from April 1 to April 8, 2006.
Abstract title and authors:
Identification of Metabolic and Protein Biomarkers for Amyotrophic Lateral Sclerosis
Paige, LA, Bowser, R, Mitchell, M, Lutka, F, An J, Ganchev, P, Gopalakrishnan, V, Newhall, KN, Kruczek, K, Welsh, E, Kaddurah-Daouk, R, Brown, RH, Cudkowicz, ME.