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Three Intermediate Expanded Access Protocols (EAP) CNMAu8.EAP01, CNMAu8.EAP02, and CNMAu8.EAP06 for ALS

ClinicalTrials.gov ID: NCT05281484

Public ClinicalTrials.gov record NCT05281484. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 12:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Three Intermediate Expanded Access Protocols for Amyotrophic Lateral Sclerosis With CNM-Au8. CNMAu8.EAP01, CNMAu8.EAP02, and CNMAu8.EAP06

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT05281484
Recruitment status
Available
Study type
Expanded access
Phase
Not listed
Lead sponsor
Clene Nanomedicine
Industry
Enrollment
Not listed

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Not listed
Last update posted
Aug 23, 2026

United States locations

U.S. sites
16
U.S. states
14
U.S. cities
16
Facility City State ZIP Site status
Barrow Neurological Institute (Enrollment is full, not recruiting) Phoenix Arizona 85013 Available
UC Irvine (Enrollment is full, not recruiting) Orange California 92868 Available
Sutter Health (Enrollment is full, not recruiting) San Francisco California 94107 Available
Hospital for Special Care (Enrollment is full, not recruiting) New Britain Connecticut 06053 Available
Nova Southeastern University (Enrollment is full, not recruiting) Davie Florida 33314 Available
Northwestern (Enrollment is full, not recruiting) Chicago Illinois 60611 Available
University of Kansas (Enrollment is full, not recruiting) Fairway Kansas 66205 Available
Massachusetts General Hospital (Enrollment is full, not recruiting) Boston Massachusetts 02114 Available
Henry Ford Health Systems (Enrollment is full, not recruiting) Detroit Michigan 48322 Available
University of Nebraska Medical Center (Enrollment is full, not recruiting) Omaha Nebraska 68198 Available
DUKE University Medical Center Durham North Carolina 27705 Available
Providence Health (Enrollment is full, not recruiting) Portland Oregon 97225 Available
Penn State Health (Enrollment is full, not recruiting) Hershey Pennsylvania 17033 Available
Jefferson Hospital (Enrollment is full, not recruiting) Philadelphia Pennsylvania 19107 Available
Texas Neurology (Enrollment is full, not recruiting) Dallas Texas 75206 Available
University of Washington (Enrollment is full, not recruiting) Seattle Washington 98195 Available

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05281484, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 23, 2026 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05281484 live on ClinicalTrials.gov.

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