This guidance document is being distributed for comment purposes only. The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of amyotrophic lateral sclerosis (ALS). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the clinical development program and clinical trial designs for drugs to support an indication for the treatment of ALS.
Trial News & Events
Of the 200-plus posters presented during the event, over 58 were submitted by NEALS members. A number of NEALS members also chaired the daily sessions, and even more presented during the meeting.
This study is designed to investigate whether there are risk factors for the development of problems with thinking, behavior and mood in Persons with Amyotrophic Lateral Sclerosis (PALS), and whether these problems affect their caregivers (e.g., spouse, adult child).
Calling all individuals with ALS and caregivers: We need your help!
Take a survey to help guide drug development for ALS
The Dominant Inherited ALS (DIALS) Network research study is recruiting participants who do not have any neurological symptoms, but who have a first-degree relative with ALS caused by a mutation in the C9orf72 or SOD1 gene. The purpose of the research study is to study a population at risk for developing ALS.
The Montreal Neurological Institute and Hospital’s Clinical Research Unit (CRU), will hold its 2nd Annual National Clinical Trial Training Program on June 15 & 16, 2017 at the Montreal Neurological Institute and Hospital.
The Northeast ALS Consortium (NEALS) was pleased to participate in The ALS Association’s 2017 National ALS Advocacy Conference, held in Washington, DC from May 14 - 16. The event brought together people with ALS, representatives of nearly every major ALS organization, and advocates from across the country, providing a forum to share ALS stories, hear about the latest research opportunities, and urge Congress to make a difference in the fight against ALS.
This year, an overwhelming number of NEALS members were invited to participate in the meeting; the membership gave multiple plenary talks, served as session chairs, participated in platform presentations, and presented abstract posters over the week-long program.
More information about Radicava (Edaravone) and when it will be available in the US.
Today, the FDA approved the drug Edaravone for the treatment of ALS. NEALS is thrilled to now have another medication for our patients. For more information on how to access Edaravone, contact the staff and physicians at your ALS Clinic.