Two Intermediate Expanded Access Protocols (EAP) CNMAu8.EAP01 and CNMAu8.EAP02 for ALS

NO_LONGER_AVAILABLE

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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).

Key facts

Study ID

NCT05281484

Run by

Clene Nanomedicine

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to understand and give written informed consent.
• Male or female participants aged 18 years or greater (inclusive) at the time of ALS diagnosis.
• 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).
• 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.
• 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).
• In the judgement of the Investigator the participant's expected survival is greater than six-months.
• 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.

You may not qualify if…

• 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.
• 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.
• Based on the investigator's judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
• Within the prior 90-days the participant has had clinically significant findings on standard hepatic, hematologic, or renal safety assays.
• Participant is currently involved in another placebo-controlled clinical trial (note: concomitant therapy with other investigational products is permitted with certain restrictions.
• 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.
• Females of child-bearing potential, or men, who are unwilling or unable to use accepted methods of birth control.
• 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).

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• UC Irvine — Orange, California, United States
• Sutter Health (Enrollment is full, not recruiting) — San Francisco, California, United States
• Hospital for Special Care (Enrollment is full, not recruiting) — New Britain, Connecticut, United States
• Nova Southeastern University — Davie, Florida, United States
• Northwestern (Enrollment is full, not recruiting) — Chicago, Illinois, United States
• University of Kansas (Enrollment is full, not recruiting) — Fairway, Kansas, United States
• Massachusetts General Hospital (Enrollment is full, not recruiting) — Boston, Massachusetts, United States
• Henry Ford Health Systems (Enrollment is full, not recruiting) — Detroit, Michigan, United States
• University of Nebraska Medical Center (Enrollment is full, not recruiting) — Omaha, Nebraska, United States
• DUKE University Medical Center (Enrollment is full, not recruiting) — Durham, North Carolina, United States
• Providence Health (Enrollment is full, not recruiting) — Portland, Oregon, United States
• Penn State Health (Enrollment is full, not recruiting) — Hershey, Pennsylvania, United States
• Jefferson Hospital (Enrollment is full, not recruiting) — Philadelphia, Pennsylvania, United States
• Texas Neurology — Dallas, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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