Amyotrophic Lateral SclerosisNCT05281484
Three Intermediate Expanded Access Protocols (EAP) CNMAu8.EAP01, CNMAu8.EAP02, and CNMAu8.EAP06 for ALS
A study testing CNM-Au8 in people with Amyotrophic Lateral Sclerosis, run by Clene Nanomedicine at 16 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- CNM-Au8
- How many people
- Not given
- Where
- 16 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
- Available
Massachusetts General Hospital (Enrollment is full, not recruiting)
Boston, Massachusetts, 02114
Alex Zhang, 617-726-1398, healeyeap@massgeneralbrigham.org
James Berry, MD
- Available
Northwestern (Enrollment is full, not recruiting)
Chicago, Illinois, 60611
Emma Schmidt, 312-503-4362, emma.schmidt@northwestern.edu
Senda Ajroud-Driss, MD
- Available
Texas Neurology (Enrollment is full, not recruiting)
Dallas, Texas, 75206
Angela Coriddi, 214-827-3610, acoriddi@texasneurology.com
Daragh Heitzman, MD
- Available
Nova Southeastern University (Enrollment is full, not recruiting)
Davie, Florida, 33314
Eduardo Locatelli, MD, 954-262-6387, eduardo.locatelli@nova.edu
- Available
Henry Ford Health Systems (Enrollment is full, not recruiting)
Detroit, Michigan, 48322
Beverley Duthie, RN, CRC, 313-916-3359, bduthie1@hfhs.org
Ximena Arcila-Londono, MD
- Available
DUKE University Medical Center
Durham, North Carolina, 27705
Michelle Ward, RN, BSN, alsresearch@duke.edu
Hailey Zampa, CRC, alsresearch@duke.edu
- Available
University of Kansas (Enrollment is full, not recruiting)
Fairway, Kansas, 66205
Katie Lillig, CCRP, 913-945-9932, kjennens2@Kumc.edu
Omar Jawdat, MD
- Available
Penn State Health (Enrollment is full, not recruiting)
Hershey, Pennsylvania, 17033
Wint Nandar, Ph.D., 717-531-8257, nervemuscle@pennstatehealth.psu.edu
Zachary Simmons, MD
- Available
Hospital for Special Care (Enrollment is full, not recruiting)
New Britain, Connecticut, 06053
Honora Dalamagas, 860-827-1958, hdalamagas@hfsc.org
Charles Whitaker, MD
- Available
University of Nebraska Medical Center (Enrollment is full, not recruiting)
Omaha, Nebraska, 68198
Deb Heimes, 402-559-4504, deb.heimes@unmc.edu
Joseph Fernandez, MD
- Available
UC Irvine (Enrollment is full, not recruiting)
Orange, California, 92868
Kaelyn McCloud, 714-456-8520, klmcclou@hs.uci.edu
Namita Goyal, MD
- Available
Jefferson Hospital (Enrollment is full, not recruiting)
Philadelphia, Pennsylvania, 19107
Amir Moghadam, 267-582-6061, Amir.Moghadamahmadi@jefferson.edu
Hristelina Ilieva, MD
- Available
Barrow Neurological Institute (Enrollment is full, not recruiting)
Phoenix, Arizona, 85013
Nicole Turcotte, 602-406-4775, fulton.research@dignityhealth.org
Shafeeq Ladha, MD
- Available
Providence Health (Enrollment is full, not recruiting)
Portland, Oregon, 97225
Ashley Adamo, 503-962-1171, ashley.adamo@providence.org
Nicholas Olney, MD
- Available
Sutter Health (Enrollment is full, not recruiting)
San Francisco, California, 94107
Bethany Parrett, 415-654-1022, clinicalresearch@sutterhealth.org
Jonathan Katz, MD
- Available
University of Washington (Enrollment is full, not recruiting)
Seattle, Washington, 98195
Kinsey Chapman, kinseyc@uw.edu
Michael Weiss, MD
About this study
Official title: Three Intermediate Expanded Access Protocols for Amyotrophic Lateral Sclerosis With CNM-Au8. CNMAu8.EAP01, CNMAu8.EAP02, and CNMAu8.EAP06
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).
Read the detailed description
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:
- A treatment period of forty-eight (48) weeks (Treatment Period 1);
- 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);
- 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- CNM-Au8
- Keywords
- Expanded access, ALS, Amyotrophic Lateral Sclerosis, CNM Au8, Au8
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNM-Au8Drug
Also called Nanocrystalline gold
CNM-Au8 is an aqueous suspension of clean surfaced faceted nanocrystals consisting of gold atoms self-organized into crystals of various geometrical shapes (hexagonal bi-pyramid, pentagonal bipyramid, tetrahedron, decahedron, planar spheroids).
Highly pure elemental Au nanocrystals are suspended in USP purified deionized water buffered with 0.546 mg/mL (6.5 mM) sodium bicarbonate (NaHCO3) nominally concentrated to up to 0.5 mg/mL (500 ppm).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Clene Nanomedicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281484
- Sponsor's protocol ID
- CNMAu8.EAP 01, 02, & 06
- Status last verified
- Aug 2026
- First submitted
- 7 Mar 2022
- Last updated
- 24 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Intermediate Expanded Access Protocols for Amyotrophic Lateral Sclerosis With CNM-Au8. CNMAu8.EAP01, CNMAu8.EAP02, and CNMAu8.EAP06
- ClinicalTrials.gov ID
- NCT05281484
- Acronym / sponsor ID
- CNMAu8.EAP 01, 02, & 06
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Expanded access, ALS, Amyotrophic Lateral Sclerosis, CNM Au8, Au8
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Clene NanomedicineIndustry (pharma, biotech, devices)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- A treatment period of forty-eight (48) weeks (Treatment Period 1);
- 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);
- 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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNM-Au8Also: Nanocrystalline goldCNM-Au8 is an aqueous suspension of clean surfaced faceted nanocrystals consisting of gold atoms self-organized into crystals of various geometrical shapes (hexagonal bi-pyramid, pentagonal bipyramid, tetrahedron, decahedron, planar spheroids). Highly pure elemental Au nanocrystals are suspended in USP purified deionized water buffered with 0.546 mg/mL (6.5 mM) sodium bicarbonate (NaHCO3) nominally concentrated to up to 0.5 mg/mL (500 ppm). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CNM-Au8 in people with Amyotrophic Lateral Sclerosis, run by Clene Nanomedicine at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Austin Rynders, BS ((801)676-9695, eap@clene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.