Expanded Access Programs
The mission of the Northeast Amyotrophic Lateral Sclerosis Consortium® (NEALS) is to translate scientific advances into new treatments for people 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 which can be helpful in overcoming these challenges.
Here is a series of short videos about different aspects of EAPs
- 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 EAPs
- Expanded Access to Investigational Drugs
- ALS Drug Development Webinar Series Part 3: Ethical Considerations
- ALS Drug Development Webinar Series Part 4: Site Considerations
Here you can see a roadmap and step by step guide to opening an EAP at a site
Here is a list of Expanded Access Protocols which are open to enrollment
- An Intermediate Expanded Access Protocol for Amyotrophic Lateral Sclerosis With CNM-Au8
Location: Massachusetts General Hospital, Boston, Massachusetts, United States, 02114
Contact: Judith Carney, RN at 617-724-8995 or email@example.com
- Expanded Access Protocol: Repeated Administration of Nurown® (Autologous MSC-NTF Cells) for the Treatment of ALS
University of California Irvine, Irvine, California, United States, 92697
Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048
California Pacific Medical Center, San Francisco, California, United States, 94115
Massachusetts General Hospital, Boston, Massachusetts, United States, 02115
UMass Medical School, Worcester, Massachusetts, United States, 01655
Mayo Clinic, Rochester, Minnesota, United States, 55905
Contacts: Mary Kay Turner at 201-488-0460 ext 105 or firstname.lastname@example.org and Yael Gothelf, Ph.D. at 646-666-3188 ext 111 or email@example.com
- Expanded Access Program for Tofersen in Participants With Superoxide Dismutase 1-Amyotropic Lateral Sclerosis
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 firstname.lastname@example.org
Click here for more information about the Sean M. Healey EAP Program at Massachusetts General Hospital.
The information on Expanded Access provided on this page is sourced from public websites. Therefore, not all EAPs included here are endorsed by the Northeast Amyotrophic Lateral Sclerosis Consortium®. If you have information about an EAP not listed above, please contact Carly Allen at email@example.com.