The ALS Association

ALS Clinical Trials Update

September 1, 2011

The ALS Association is pleased to report that there are a number of interesting clinical trials ongoing, and we encourage active participation to ensure full enrollment.  In addition, we stress the importance of remaining committed to the trials; dropping out or switching from one trial to another can skew the data and impact the accuracy of the results.

ALS Trial Expert Available:  As announced in August 2011, the Northeast ALS Consortium (NEALS) in conjunction with The ALS Association has established a new, centralized resource for information about amyotrophic lateral sclerosis (ALS) clinical research.  An ALS clinical trial expert can be reached at (877) 458-0631 Monday through Friday between 9 a.m. and 5 p.m. Eastern Time and by e-mail at alstrials@partners.org.  In addition, NEALS is updating their clinical research Website.  Visit http://www.alsa.org/news/archive/als-trial-expert-available.html to read the full announcement.

Neuraltus Pharmaceuticals NP-001 Trial
This Phase 2 trial is expected to enroll105 patients across 15 sites in the U.S. and is approximately three-quarters filled.  Results are not expected until mid-to-late 2012.  The ALS Association encourages all eligible participants to enroll in this trial.  For study details, visit http://clinicaltrials.gov/ct2/show/NCT01281631?term=NP001&rank=2.

Dexpramipexole Phase 3 Study of ALS:  Biogen Idec and Knopp Biosciences announced yesterday, August 30, that due to a highly successful participant recruiting process, researchers have suspended the initial screening process.  However, the evaluation of participants who have begun the screening process will continue to determine if they meet the study criteria, and Biogen anticipates that the trial will be fully enrolled with the month.  The company is encouraged by this milestone in the development of dexpramipexole as a potential new therapy for ALS.  Patients are advised to consult their treating physicians for additional information.  In addition, Biogen’s Patient Services Team is available Monday through Friday 8:30 a.m. to 8 p.m. Eastern Time, at (877) 312-9676 in the U.S. or (919) 933-7311 for caller outside the U.S.; then select option 2 for ALS Clinical Trials.

Ceftriaxone Study Webinar – September 26:  Dr. Merit Cudkowicz, Principal Investigator for the Ceftriaxone study, will hold an informational web seminar for people with ALS interested in learning more about the clinical trial of Ceftriaxone for ALS.  This will be a time to learn about the scientific rationale behind the study and learn about study procedures.  Merit Cudkowicz, M.D., M.Sc. and Jeremy Shefner, M.D., Ph.D. will be available to answer questions.  Interested people can join the seminar on Monday, September 26, 2011 at 2 p.m. Eastern Time.  For more information, contact: Stitus@partners.org.

Webinar Registration Instructions:
1. To register visit: https://www1.gotomeeting.com/register/151881345
2. Early online registration is recommended as space is limited, at least a day or two before the seminar.  After registering you will receive a confirmation email containing information about joining the Webinar, including dial-in information.

The program will ask that you enter your first and last name upon registration.  In the interest of privacy, we ask that you enter your initials only or your first name and last initial.  The “Go-To-Webinar” software is compatible with PC Based Windows® 7, Vista, XP or 2003 and Server Macintosh Based Mac OS® X 10.4.11 (Tiger®) or newer.  This study is taking place in the United States and Canada.

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