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Quick Info
Trial Type
Expanded Access
Treatment Type
Drug Trials
Start Date
Contact Information
United States, Arizona
Barrow Neurological Institute, Phoenix, AZ, 85013, United States
Contact: Nicole Turcotte   602-406-4775
United States, California
UC Irvine, Orange, CA, 92868, United States
Contact: Kaelyn McCloud   714-456-8520
Sutter Health, San Francisco, CA, 94107, United States
Contact: Bethany Parrett   415-654-1022
United States, Connecticut
Hospital for Special Care, New Britain, CT, 06053, United States
Contact: Honora Dalamagas   860-827-1958
United States, Florida
Holy Cross Hospital, Davie, FL, 33314, United States
Contact: Gustavo Alameda, MD   954-414-9750
Nova Southeastern University, Davie, FL, 33314, United States
Contact: Eduardo Locatelli, MD   954-262-6387
United States, Illinois
Northwestern, Chicago, IL, 60611, United States
Contact: Emma Schmidt   312-503-4362
United States, Kansas
University of Kansas, Fairway, KS, 66205, United States
Contact: Katie Lillig, CCRP   913-945-9932
United States, Michigan
Henry Ford Health Systems, Detroit, MI, 48322, United States
Contact: Beverley Duthie, RN, CRC   313-916-3359
United States, Nebraska
University of Nebraska Medical Center, Omaha, NE, 68198, United States
Contact: Deb Heimes   402-559-4504
United States, North Carolina
DUKE University Medical Center, Durham, NC, 27705, United States
Contact: Michelle Ward, RN, BSN   919-613-2681
United States, Oregon
Providence Health, Portland, OR, 97225, United States
Contact: Ashley Adamo   503-962-1171
United States, Pennsylvania
Penn State Health, Hershey, PA, 17033, United States
Contact: Wint Nandar, Ph.D.   717-531-8257
University of Pennsylvania, Philadelphia, PA, 19104, United States
Contact: Adreeja GuhaRay, MPH   215-313-3966
Jefferson Hospital, Philadelphia, PA, 19107, United States
Contact: Yesasvini Devabhaktuni   267-582-6061
United States, Texas
Texas Neurology, Dallas, TX, 75206, United States
Contact: Angela Coriddi   214-827-3610
Trial Goal
Tests to Expect
Update Notes
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EAP availible
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Sites removed/added
Expanded access no longer available
Study added

Other Information

The primary objective of the intermediate expanded access protocol is to provide access to the investigational product, CNM-Au8, to up to 300 people living with ALS (pALS). No formal clinical hypotheses are being evaluated with concurrent controls. Secondary objectives include assessment of the safety of CNM-Au8 treatment in pALS. Safety will be assessed through the frequency of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs) assessed as 'severe', discontinuations due to TEAEs, and laboratory abnormalities assessed as clinically significant during routine clinical monitoring (as applicable).
Inclusion Criteria:
1. Able to understand and give written informed consent.
2. Male or female participants aged 18 years or greater (inclusive) at the time of ALS diagnosis.
3. Participants with a confirmed diagnosis of ALS per Gold Coast criteria as determined by a neurologist specializing in ALS (e.g., the site principal investigator or sub-investigator for this study).
4. Participant is able to daily consume up to 240 mL of the investigational drug suspension without substantial dysphagia, OR can intake the investigational product through a gastrostomy tube.
5. Participant must have completed standard clinical safety labs within the prior 90 days from the Baseline visit including a chemistry panel (e.g., CMP) and a hematology panel (e.g., CBC).
6. In the judgement of the Investigator the participant's expected survival is greater than six-months.
7. Participants who have established care with a neurologist at the specialized ALS center involved in the study and will maintain this clinical care throughout the duration of the EAP within the United States.
OR Prior participation in the HEALEY Platform ALS trial (Regimen C) Open Label Extension (NCT04414345) will be considered an automatic inclusion.
Exclusion Criteria:
1. Participant is eligible for participation in: (i) the HEALEY ALS Platform trial (NCT04297683), or (ii) any active study investigating CNM-Au8 for the treatment of ALS.
2. Participant has a history of any clinically significant or unstable medical condition (other than ALS) that may interfere with assessment of safety or compromise the study objectives.
3. Based on the investigator's judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
4. Within the prior 90-days the participant has had clinically significant findings on standard hepatic, hematologic, or renal safety assays.
5. Participant is currently involved in another placebo-controlled clinical trial (note:
concomitant therapy with other investigational products is permitted with certain restrictions.
6. Females who are pregnant or nursing or who plan to get pregnant during the EAP or within 6 months of the end of this trial.
7. Females of child-bearing potential, or men, who are unwilling or unable to use accepted methods of birth control.
8. History of gold allergy.
OR These exclusion criteria will not be applied if the participant was previously enrolled in the HEALEY Platform ALS trial (Regimen C) Open Label Extension (NCT04414345).
This is a multi-center intermediate expanded access program to provide access to the investigational product, CNM-Au8, up to 300 participants diagnosed with ALS. The safety of CNM-Au8 treatment in ALS participants will be evaluated. Visits will occur at a clinic or remotely via telephone or video-visit. Visits may be conducted remotely due to COVID-19-related pandemic concerns, or if due to ALS disease progression. Participants who meet the inclusion criteria and none of the exclusionary criteria may be enrolled into the EAP. There will be three study periods: 1. A treatment period of forty-eight (48) weeks (Treatment Period 1); 2. Additional optional follow-on treatment period(s) of up to forty-eight (48) weeks duration may be added at the discretion of the Sponsor and Site Investigator (e.g., Treatment Period 2, Treatment Period 3); 3. A four (4) week safety follow-up period (End-of-Study [EOS]Assessment). All participants will receive open-label oral treatment daily up to 48 weeks during Treatment Period 1. Additional 48-week treatment periods may be approved at the discretion of the Sponsor. The EAP may be discontinued at any time at the Sponsor's discretion. At treatment discontinuation or following the end of the participant's final Treatment Period, participants will complete an end-of-study (EOS) assessment 4 weeks following discontinuation of the investigational drug product. Visit assessments may be collected remotely, via tele-visit with study site staff. Investigational product may be shipped by the site to participants who do attend in-clinic visits.
Trial Protocol as Published on
NCT05281484 (First Published: 3/7/2022)