ALSNCT06408727
Intermediate Expanded Access Protocol CNMAu8.EAP04
A study testing CNM-Au8 in people with ALS and Amyotrophic Lateral Sclerosis, run by Clene Nanomedicine at 8 sites in United States.
Trial summary
An Intermediate Expanded Access Protocol (EAP) with CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALS, Amyotrophic Lateral Sclerosis, PALS
- What is being tested?
- CNM-Au8
- How many people
- Not given
- Where
- 8 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 informed consent completion.
- 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 60 mL of the investigational drug suspension without substantial dysphagia, OR can intake the investigational product through a feeding 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).
- Participant has a baseline score by the TRICALS risk calculator that is less than -2 (i.e., participant is not at increased risk of early death; https://tricals.shinyapps.io/risk-profile/).
Show all 11Show fewer
- Participant meets the following criteria:
- Baseline Vital Capacity >15% predicted,
- Baseline ALSFRS-R Score >8, and,
- Baseline BMI >17.5 kg/m2
- Participants have established care with a neurologist at the specialized ALS center or remotely enrolling site involved in the study and will maintain this clinical care throughout the duration of the EAP within the United States.
Who cannot join
- Participant is eligible for participation in any double-blind placebo-controlled study the treatment of ALS at the same research site.
- 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, including but not limited to: (i) ALT or AST ≥ 3 times upper limits of normal, (ii) direct (conjugated) with bilirubin ≥2 times upper limits of normal, (iii) low platelet counts (< 150 x 109 per liter) or eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter), (iv) serum creatinine >1.2 mg/dL, or (v) eGFR < 45 ml/min per 1.73 m2.
- Participant is currently involved in another placebo-controlled clinical trial (note: concomitant therapy with other investigational products is permitted with certain restrictions-see concomitant medications below).
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Northwestern University
Chicago, Illinois, 60611
Synapticure
Chicago, Illinois, 60613
Texas Neurology
Dallas, Texas, 75206
Duke University
Durham, North Carolina, 27704
Nova Southeastern University
Fort Lauderdale, Florida, 33328
Pennsylvania State University
Hershey, Pennsylvania, 17033
University of Iowa
Iowa City, Iowa, 52242
Columbia Unniversity
New York, New York, 10032
About this study
Official title: An Intermediate Expanded Access Protocol With CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012
An Intermediate Expanded Access Protocol (EAP) with CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012
Read the detailed description
An Intermediate Expanded Access Protocol (EAP) with CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012. The primary objective of this intermediate EAP is to provide access to the investigational product, CNM-Au8 30mg, for up to 180 people living with ALS.
- Conditions
- ALS, Amyotrophic Lateral Sclerosis, PALS
- Being tested
- CNM-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
CNM-Au8 (cellular energetic nanocatalyst). Faceted clean-surfaced catalytically-active Au nanocrystals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies 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)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408727
- Sponsor's protocol ID
- CNMAu8.EAP04
- Other IDs
- 1U01NS136023-01
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intermediate Expanded Access Protocol With CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012
- ClinicalTrials.gov ID
- NCT06408727
- Acronym / sponsor ID
- CNMAu8.EAP04
- Conditions
- ALS, Amyotrophic Lateral Sclerosis, PALS
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Clene NanomedicineIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- First posted
- 10 May 2024 (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.
An Intermediate Expanded Access Protocol (EAP) with CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012
Detailed description
An Intermediate Expanded Access Protocol (EAP) with CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012. The primary objective of this intermediate EAP is to provide access to the investigational product, CNM-Au8 30mg, for up to 180 people living with ALS.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able to understand and give written informed consent.
- Male or female participants aged 18 years or greater (inclusive) at the time of informed consent completion.
- 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 60 mL of the investigational drug suspension without substantial dysphagia, OR can intake the investigational product through a feeding 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 (8 listed)
- Participant is eligible for participation in any double-blind placebo-controlled study the treatment of ALS at the same research site.
- 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, including but not limited to: (i) ALT or AST ≥ 3 times upper limits of normal, (ii) direct (conjugated) with bilirubin ≥2 times upper limits of normal, (iii) low platelet counts (< 150 x 109 per liter) or eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter), (iv) serum creatinine >1.2 mg/dL, or (v) eGFR < 45 ml/min per 1.73 m2.
- Participant is currently involved in another placebo-controlled clinical trial (note: concomitant therapy with other investigational products is permitted with certain restrictions-see concomitant medications below).
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-Au8CNM-Au8 (cellular energetic nanocatalyst). Faceted clean-surfaced catalytically-active Au nanocrystals. | 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 7 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 ALS and Amyotrophic Lateral Sclerosis, run by Clene Nanomedicine at 8 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 11 inclusion and 8 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 7 Apr 2026.