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Intermediate Expanded Access Protocol CNMAu8.EAP04 | Clinical Trials | Clareo Health

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Intermediate Expanded Access Protocol CNMAu8.EAP04

An Intermediate Expanded Access Protocol With CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012

NCT06408727•Clene Nanomedicine

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 informed consent completion.
•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 60 mL of the investigational drug suspension without substantial dysphagia, OR can intake the investigational product through a feeding 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. 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/).
•7. Participant meets the following criteria:
•1. Baseline Vital Capacity \>15% predicted,
•2. Baseline ALSFRS-R Score \>8, and,
•3. Baseline BMI \>17.5 kg/m2
+1 more criteria

Exclusion Criteria

•1. Participant is eligible for participation in any double-blind placebo-controlled study the treatment of ALS at the same research site.
•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, 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.
•5. 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).
•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.

Locations (8)

Nova Southeastern University

Fort Lauderdale, Florida, United States

Northwestern University

Chicago, Illinois, United States

Synapticure

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Columbia Unniversity

New York, New York, United States

Duke University

Durham, North Carolina, United States

Pennsylvania State University

Hershey, Pennsylvania, United States

Texas Neurology

Dallas, Texas, United States

Key Dates

Last Updated

January 28, 2025

Conditions

ALSAmyotrophic Lateral SclerosisPALS

Interventions

CNM-Au8

DRUG

Contacts

Austin Rynders, BS

CONTACT

(801)676-9695 eap@clene.com

Jeremy Evan, PA-C

CONTACT

(801)676-9695 eap@clene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intermediate Expanded Access Protocol CNMAu8.EAP04

Inclusion Criteria

Exclusion Criteria

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