Expanded Access
The mission of the Northeast Amyotrophic Lateral Sclerosis Consortium® (NEALS) is to translate scientific advances into new treatments for people living with Amyotrophic Lateral Sclerosis (ALS). In addition to conducting clinical trials, NEALS is committed to sharing information about Expanded Access to investigational therapies.
Here you can read an article that describes Expanded Access Programs, compares them to other pathways for accessing investigational treatments, describes some of the challenges at the sponsor and site level, and lists resources that can help overcome these challenges.
Here is a series of short videos about different aspects of Expanded Access
- What Are “Expanded Access Programs” and Who Qualifies for Them?
- How Does Expanded Access Differ from Other Options for PALS Who Want to Access Investigational Products?
- Barriers to Expanded Access Programs and Resources for Addressing Them
Here you can watch longer Educational Webinars containing information about Expanded Access
- Expanded Access to Investigational Drugs
- ALS Drug Development Webinar Series Part 3: Ethical Considerations
- ALS Drug Development Webinar Series Part 4: Site Considerations
- The Latest on Expanded Access Protocols in ALS
Here you can see a roadmap and step by step guide to opening an Expanded Access Program at a site
Here is a list of some of the active Expanded Access Protocols. Please note that each protocol has its own list of inclusion and exclusion criteria and not every person living with ALS will qualify. If you have information about an Expanded Access Protocol not listed below, please contact Carly Allen, NEALS Communications and Outreach Manager, at callen@neals.org.
- Drug/Intervention: CNM-Au8
Location: Massachusetts General Hospital, Boston, Massachusetts, United States, 02114
Contacts: Allison Winter at 617-724-7398 or adwinter@mgh.harvard.edu and Geli Kane at 617-726-1531 or gckane@mgh.harvard.edu
Learn More - Drug/Intervention: RNS60
Location: Massachusetts General Hospital, Boston, Massachusetts, United States, 02114
Contacts: Grace Addy at 617-726-4282 or gaddy@mgh.harvard.edu and Dario Gelevski at 617-726-0563 or dgelevski@mgh.harvard.edu
Learn More - Drug/Intervention: IC14
Location: Massachusetts General Hospital, Boston, Massachusetts, United States, 02114
Contacts: Dario Gelevski at 617-726-0563 or dgelevski@mgh.harvard.edu and Caroline Cohen at 617-643-7828 or ccohen0@mgh.harvard.edu
Learn More - Drug/Intervention: AMX0035
Location: Multicenter
Contact: Patient Access Bionical Emas at 888-704-9397 or patient.access@bionical-emas.com
Learn More - Drug/Intervention: Pridopidine
Location: Multicenter
Learn More - Drug/Intervention: Verdiperstat
Location: Multicenter
Learn More - Drug/Intervention: CNM-Au8
Location: Multicenter
Learn More - Drug/Intervention: Tofersen
Location: The current EAP structure does not limit patients to receive access at specific sites
Contact: US Biogen Clinical Trial Center at 866-633-4636 or clinicaltrials@biogen.com
Learn More - Drug/Intervention: NurOwn (MSC-NTF cells)
Location: Multicenter
Contacts: Mary Kay Turner at 201-488-0460 ext 105 or mkt@brainstorm-cell.com and Yael Gothelf, Ph.D. at 646-666-3188 ext 111 or ygothelf@brainstorm-cell.com
Learn More
Here you can find additional resources for clinicians
DISCLAIMER CONCERNING INFORMATION ABOUT EXPANDED ACCESS
The information is provided “as is.” NEALS shares information concerning Expanded Access as a public service, for general information purposes only. The information is gathered from other public websites and is made available without evaluation or endorsement by NEALS. It may be incomplete, outdated, or irrelevant to a particular reader’s situation. By providing this information, NEALS is not recommending any treatment to individual patients.